Recall Z-1234-2022 · FAJ Cystoscope And Accessories, Flexible/Rigid

Karl Storz Endoscopy

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

Date	May 3, 2022
Status	Open, Classified
Reason	The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
Root cause	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 identifi
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.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K202957

Flexible Video Cysto-Urethroscope (C-view)
KARL STORZ Endoscopy-America, Inc., Oct 29, 2020