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U.S. Department of Health and Human Services

Class 2 Device Recall KARL STORZ Flexible Video CystoUrethroscopes (CVIEW)

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  Class 2 Device Recall KARL STORZ Flexible Video CystoUrethroscopes (CVIEW) see related information
Date Initiated by Firm May 03, 2022
Create Date June 03, 2022
Recall Status1 Open3, Classified
Recall Number Z-1234-2022
Recall Event ID 90025
510(K)Number K202957  
Product Classification Cystoscope and accessories, flexible/rigid - Product Code FAJ
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
Code Information 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 60385 60885 61228 59401 59632 59820 59968 60153 60386 60948 61230 59402 59633 59821 59969 60154 60416 60949 61236 59416 59635 59822 59970 60159 60417 61109 61238 59418 59637 59839 59971 60160 60418 61110 61242 59420 59639 59840 60001 60161 60430 61111 61243 59495 59640 59842 60002 60162 60520 61114 61246 59497 59660 59848 60003 60193 60522 61115 61253 59581 59662 59851 60004 60201 60525 61116 61257 59582 59663 59853 60005 60202 60526 61136 61258 59584 59664 59856 60007 60203 60527 61137 61259 59587 59665 59888 60008 60205 60752 61139 61270 59589 59666 59890 60025 60297 60775 61140 61300 59592 59667 59891 60027 60299 60776 61155 62618 59593 59668 59892 60064 60300 60778 61156 59594 59692 59896 60066 60301 60780 61190 59600 59694 59897 60067 60312 60820 61191 59602 59695 59921 60068 60314 60838 61192 59603 59699 59935 60076 60315 60839 61193 59604 59813 59936 60077 60331 60841 61194 59628 59814 59938 60079 60350 60859 61224 Scope Kit Number(s): 11272VUK-R Scope Kit Part Number: 11272VUEK-R UDI Code-DI: 4048551444351 Serial Numbers: 25894 37977 48678 58399 59872 60163 60316 60930 25898 38237 49374 58424 59873 60164 60325 61141 27983 38542 49376 58467 59874 60208 60388 61142 30293 40571 51596 58468 59875 60209 60420 61232 31667 40572 55498 58512 59876 60298 60429 61234 31730 40706 57611 58645 60022 60302 60512 61268 32409 44105 58122 58711 60023 60303 60724 61269 34423 46522 58398 59554 60024 60304 60836 62359
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information Contact Sedgwick
877-877-0317
Manufacturer Reason
for Recall		 The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
FDA Determined
Cause 2		 Process control
Action 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
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FAJ and Original Applicant = KARL STORZ Endoscopy-America, Inc
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