MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE

Model Number	A0393
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the connection cable had a spark from the resectoscope of the cautery cord.The surgeon¿s hand was hit by the spark and needed to change surgical gloves after the incident.The issue occurred during a transurethral resection of bladder tumor procedure.The procedure was completed with a similar device.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation and from the information obtained, the cause of the reported issue is most likely due to wear and tear in connection which can cause a voltage spike at the damaged area when the generator was activated, resulting in a spark.The root cause could not be identified.In order to avoid such incidents, the instructions found in the instructions for use (ifu) should be followed.This would be, firstly, that the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Additionally, the cable must be checked for damage before each use and after reprocessing.By gently pulling on the plug (max.20n), it can be determined whether the copper strand of the cable is already damaged.If the cable does not give way but remains rigid, the cable is most likely intact.In order not to shorten the service life of the cable any further, the cable should not be wound up with a loop diameter of less than 10cm and when pulling out the cable, the plug should be pulled and not the cable.Olympus will continue to monitor the field performance of this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20157889
• Report Number: 9610773-2024-02146
• Device Sequence Number: 14512202
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: A0393
• Device Lot Number: 306019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown