Recall Z-1234-2022
Karl Storz Endoscopy · initiated May 3, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT
Codes / lots: Scope Base Part Number(s): 11272VUE Scope Kit Part Number: 11272VUEK UDI Code-DI: 4048551431382 Serial Numbers: 25407 32321 38539 53439 58011 58143 58546 59051 25408 32389 40370 53574 58020 58144 58557 59063 25410 32391 40371 53575 58021 58145 58558 59093 25766 32417 40707 53589 58022 58156 58567 59094 28096 32994 40708 53593 58045 58157 58569 59095 28257 33787 41249 53627 58046 58183 58570 59096 28919 33802 44912 53628 58047 58184 58663 59098 29286 33804 45546 53632 58048 58185 58665 59122 29342 33905 46190 53634 58058 58423 58695 59125 30054 33907 46198 53637 58060 58445 58722 59152 30881 34465 47625 53737 58062 58446 58723 59153 31033 34724 47669 53776 58073 58449 58730 59179 31036 34725 48191 53833 58074 58451 58731 59201 31038 35188 48462 53834 58075 58476 59005 59202 31300 36020 48540 54289 58078 58498 59006 59203 31302 36371 48553 57603 58087 58503 59007 59223 31374 36470 49090 57606 58088 58506 59032 59342 31413 36583 49165 57607 58089 58508 59033 59343 31533 36820 52783 57609 58090 58516 59034 59344 31622 37462 53204 57610 58125 58517 59038 59345 31964 38536 53429 57986 58142 58545 59048 59398 59399 59630 59815 59939 60080 60352 60860 61226 59400 59631 59819 59940 60151…
Reason for recall
The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
FDA-determined cause: Process control
Action taken
On April 29, 2022, KARL STORZ sent an "Urgent Medical Device Recall Notice" Letter via UPS and posting to their website "https://urldefense.com/v3/__https://www.karlstorzcustomerupdates.com/wp-content/uploads/2022/04/C-View-Recall-Customer-Notice.pdf__;!!Lw1uGqvHvtJ_psGG2Et-1voSwbo!bg5okg2Sm91SJG6RWtBKXJ258Z4YgfwOv4ZIuU_ZuW_tH2G1X_CNLBZeGB0YWAZEjDZ4j_-Hvlm6xzzWmhKnBU6U10FQtQHO$" informing customers that certain serial numbers of the Flexible Video Cysto-Urethroscope may exhibit temporary loss of image when monopolar electrocautery is activated. Customers who are in possession of the identified scopes should discontinue use of the affected scopes and return them to KARL STORZ for replacement. Customers can confirm that Endoscope is part of the Recall by comparing the serial number to the serial numbers list in the Appendix. In addition, if customers have already returned any affected scope(s) as part of the Reprocessing Methods Recall, they must still complete the enclosed Acknowledgment Form for this recall and return it as soon as possible via the contact information specified on the form. If customer's Acknowledgment Form for the Reprocessing Methods Recall indicated that they have access to an appropriate sterilization method to sterilize the affected flexible endoscopes, then they will be eligible to have their C-View Endoscope(s) replaced by KARL STORZ. If they have not returned their Acknowledgment Form for the Reprocessing Methods Recall or if their Acknowledgement Form indicated that they do not have access to an appropriate sterilization method, then KARL STORZ will not be able to replace their C-View Endoscope(s) at this time. For questions regarding this action, please use the contact information provided below for the recall execution partner, Sedgwick: Telephone: 877-877-0317 Fax: 877-597-9587 E-Mail: karlstorz2935@sedgwick.com
Details
- Recall number
- Z-1234-2022
- Initiated
- May 3, 2022
- Product code
- FAJ – Cystoscope And Accessories, Flexible/Rigid
- Quantity
- 401 units
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, and WY. The country of Canada.
- Recalling firm
- Karl Storz Endoscopy, El Segundo, CA