Recall Z-0552-2019
Medtronic Navigation, Inc. · initiated September 26, 2018
Class I – dangerous or defective products that could cause serious health problems or death
Product
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is an accessory to your StealthStation System. . . The Biopsy Needle is a presterilized , single-use, side-cutting needle for cranial tissue biopsies. CE 0344 Rx Only 2017-05 9733068-01 Medtronic Navigation, Inc.
Codes / lots: Product Number/CFN Affected Software Versions 9733763 2.2.0, 2.2.5, 2.2.6, 2.2.7 Synergy Cranial 9735585 3.0.0, 3.0.1, 3.0.2, 3.1.0 StealthStation S7 Cranial Kit CFN and UDI: CFN GTIN Description 9733763 00613994408174 SOFTWARE, 9733763, SYNERGY CRANIAL S7 9734068 00613994546081 SFTWR KIT 9734068 SYN CRANI S7 PLNG STN 9734068 00643169038110 SFTWR KIT 9734068 SYN CRANI S7 PLNG STN 9733937 00613994467102 Software Kit 9733937 Synergy Cranial S7 9733937 00643169037946 Software Kit 9733937 Synergy Cranial S7 9733928 00613994467126 Upgrade Prgm 9733928 Treon to S7 220V 9734261 00613994792884 UPGRD PRGM 9734261 StealthStation S7 9734261-G02 00643169510531 UPGRD PRGM 9734261 StealthStation S7 9734849 00613994944986 UPGD PRGM 9734849 S7 CPTL ENH PRGM 9735064 00643169192140 UPGRD PRGM 9735064 KAISER TREON TO S7 9735328 00643169332645 UPGRD PRGM 9735328 Stealth S7 Touch¿ 9735328-G02 00643169510548 UPGRD PRGM 9735328 Stealth S7 Touch 9733937-G02 00643169353305 Software Kit 9733937 Synergy Cranial S7 9733763-G03 00643169503311 SOFTWARE, 9733763, SYNERGY CRANIAL S7 9733937-G03 00643169481275 SOFTWARE KIT 9733937 SYNERGY CRANIAL S7 9733928-G02 00643169502611 UPGRADE PRGM 9733928 TREON TO S7…
Reason for recall
An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
FDA-determined cause: Device Design
Action taken
On 09/26/2018, the firm sent an Urgent Medical Device Correction Notification to all US customers informing them of potential inaccuracy during biopsy procedures using the StealthStation S7 Depth Gauge feature on StealthStation S7 and i7 systems running Synergy Cranial and StealthStation Cranial software that could result in healthy tissue being biopsied. The notification letter stated, In navigated biopsy procedures, where the Navigate Projection feature is used and the projection is longer than the length of the plan, the graphical Biopsy Depth Gauge feature can display inaccurate information. The Biopsy Needle Depth Gauge is a numerical and graphical representation of the needle cutting window in the Guidance view quadrant to assist in visualization of the cutting window position. During a biopsy procedure, the monitor shows four quadrants (Trajectory 1, Trajectory 2, Guidance, and Probe s Eye views) as well as the Biopsy Depth Gauge. The overlay of the Biopsy Needle within the anatomical views accurately indicates the correct tip location of the instrument. However, if Navigate Projection is selected, and the projection is longer than the length of the plan, then the Biopsy Depth Gauge graphical display inaccurately depicts that the tip of the instrument has not yet reached the plan target. Since 2011, Medtronic has received seven (7) complaints potentially related to this software anomaly, one in which healthy tissue was biopsied. The image on page two contains an example of the error use case. All views correctly show that the instrument is past the target, and the Depth Gauge correctly displays the past-target measurement of -63, which indicates the instrument tip has advanced 63 mm beyond the intended target. However, the graphical Biopsy Needle cut window appears not to have advanced to the target position. If the surgical team relies solely on the graphical representation in the Biopsy Depth Gauge feature and disregards other factors (such as
Details
- Recall number
- Z-0552-2019
- Initiated
- September 26, 2018
- Posted by FDA
- December 29, 2018
- Terminated
- September 5, 2024
- Product code
- HAW – Neurological Stereotaxic Instrument
- Quantity
- 5487 impacted systems
- Distribution
- US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY OUS: Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China…
- Recalling firm
- Medtronic Navigation, Inc., Louisville, CO