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

Model Number 11272VUEK

Device Problem Grounding Malfunction (1271)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Shorts out when used with cautery.

Manufacturer Narrative

The device was returned for evaluation and the following root cause activities were performed: ten (10) scopes were disassembled and evaluated in an effort to determine root cause(s).The following conditions were observed that contributed to image failures from the use of electrocautery.1.Impedance specification for the scope is not clearly documented in the design specification.2.Torque requirement was not specified in the design but is important because it compresses the nut.And the cable to the d-shape flange.- torque on the lock nut is critical to achieve the impedance and ground bond necessary for the device's immunity to conducted and radiated emissions from nearby electronics.3.Current design does not provide feedback to the assembler to know when proper engagement of the cable d-shape flange to the d-shape hole is achieved.4.The design relies on the compressive force of the o-ring to maintain contact of the nut to the housing.5.Excess krytox/silicone at the location where it gets applied.6.Proper tool for tightening the nut was not consistently utilized.7.Oxidation in the masked surface of the housing prevents proper grounding between the housing and the nut to cable.Subsequent to the initial complaint analysis, additional investigation and analysis were performed as part of capa 21-0106 and hhe 21-004.Based on the conclusion of the hhe that the risk level is not acceptable, a field action reportable to fda under 21.Cfr part 806 is being initiated.Consistent with the recommendations in fda's 2016 "medical device reporting for manufacturers" guidance, this complaint is now deemed to be reportable.File attachments.

• Brand Name: CMOS VIDEO CYSTO-URETHROSCOPE C-VIEW
• 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: 14244276
• MDR Text Key: 299376136
• Report Number: 1221826-2022-00047
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/28/2022

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
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: PENDING
• Patient Sequence Number: 1
• Patient Outcome(s): Other