MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW REV DEF; FLEXIBLE VIDEO CYSTO SCOPE

Model Number 11272VUEK

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned by the facility.

Event Description

During a procedure, image on screen would black out while hitting the cautery button.No patient injury was reported.

Manufacturer Narrative

Per evaluation findings: image interruption due to esu (electrosurgical unit) failure, ccu cable.Over bend on shaft 60mm from shaft adaptor.Dents on distal tip.Image interruption due to esu (electrosurgical unit) failure, ccu cable.This failure mode was confirmed and has been determined to be due to the durability of the power cable.

• Brand Name: CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW REV DEF
• Type of Device: FLEXIBLE VIDEO CYSTO SCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15027541
• MDR Text Key: 295972624
• Report Number: 1221826-2022-00120
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11272VUEK
• Device Catalogue Number: 11272VUEK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other