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

Model Number R11272VUEK

Device Problem Unexpected Shutdown (4019)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Image interruption, the monitor kept shorting out and restarting when using cautery.The procedure was completed.The facility provided no additional information.

Manufacturer Narrative

Per kse/mfr.Evaluation is pending.

Manufacturer Narrative

Image interruption due to esu (electrosurgical unit) failure.External cut on shaft behind proximal thread wrap, leaks.Over bend on proximal shaft 65mm from shaft adaptor.Light guide pulled back from distal head causing low light output, 30mw.Over temperature dot triggered at 180°f.Risk management file has been reviewed and this hazard is covered.This failure mode was confirmed and has been determined to be due to the durability of the power cable.Iaf 2022-07-25-01 has been filed for capa consideration.Capa 2022-0111 has been entered.

• 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: 15093886
• MDR Text Key: 304223382
• Report Number: 1221826-2022-00128
• 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: 11/10/2022

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: R11272VUEK
• Device Catalogue Number: R11272VUEK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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