MAUDE Adverse Event Report: KARL STORZ ENDOVISION CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW

Model Number 11272VUEK

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal case # (b)(4).

Event Description

It was reported that, during a cystoscopy on (b)(4) 2023, the scope glitches when a bugbee (monopolar electrocautery) is used.No harm to patient, user or third reported.The procedure was completed with a back-up scope.

Manufacturer Narrative

Per evaluation findings by the manufacturer: primary damage location: shaft exterior.Primary damage type: overbend, proximal section.Primary damage cause: maintenance and care.Details: overbend in shaft at strain relief tip.Voids in epoxy at distal window and light guides.Nicks in handle housing.

• Brand Name: CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW
• Type of Device: CYSTO-URETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 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 ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16945822
• MDR Text Key: 315395271
• Report Number: 1221826-2023-00102
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04048551431405
• UDI-Public: 4048551431405
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1