MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; HF-CABLE, MONOPOLAR CABLE, REUSABLE

Model Number	A00012A
Medical Device Problem Codes	Break (1069); Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported the user was performing a therapeutic transurethral resection of the prostate (turp) procedure and heard a loud snap.The snap was the hf cable - a00012a breaking apart close to where it was connected to the generator.A small fire created on the cable where it had come apart was observed.The procedure was completed.The problem did not have an impact to the outcome of the procedure.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on response to follow up and device evaluation.Device evaluation noted a mechanical damage, the blue straight plug housing was detached from the cable.In addition, communication with service business center representative informed that the device would not be repair, only replaced.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The manufacturing date is unknown.Based on the results of the investigation, the definitive root cause of the cable issue could not be determined.It is possible that the issue occurred because something bumped into the plug during the procedure.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: HF-CABLE, MONOPOLAR CABLE, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 16729684
• Report Number: 9610773-2023-01025
• Device Sequence Number: 6673584
• Product Code: GCP
• UDI-Device Identifier: 04042761029445
• UDI-Public: 04042761029445
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: A00012A
• Device Catalogue Number: A00012A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 06/22/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/20/2023; 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.WORKING ELEMENT ELECTRODE.
• Patient Sex: Unknown