MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	A0393
Medical Device Problem Codes	Break (1069); Fire (1245); Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the high frequency-cable, monopolar sparked, smoked and then caught fire.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the cable broke, the high frequency cable made a popping sound, then sparked.The issue was found during a trans urethral resection of bladder tumor procedure.The procedure was completed with a similar device.The procedure was delayed by 5 minutes.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information.
Additional Manufacturer Narrative
This report is also being supplemented to provide additional information based on 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, the definitive root cause of the reported event could not be determined due to lack of device return.Considerations: - the error description provided is plausible.The error described is a known error pattern and can be confirmed.The age-related wear in connection with repeated extreme bending or tensile loads most likely led to the breakage of single or all the wires in the cable.It should be noted that this can cause a voltage spike at the damaged area when the generator is activated, resulting in a spark and complete disconnection of the plug.- it is evident from the lot number that the cable was manufactured in august of 2018.It can therefore be assumed that the cable was used for longer than the specified 12 months.According to our investigators, the cause of the reported issue is most likely due to wear and tear in connection with improper handling.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18298353
• Report Number: 9610773-2023-03575
• Device Sequence Number: 7034940
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

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: 832580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 06/21/2024
• Initial Report FDA Received Date: 12/09/2023
• Supplement Report FDA Received Date: 12/12/2023; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• 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