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

Model Number	A0358
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the monopolar high frequency cable was broken.The user was imaging inside the patient and the cautery screen gave a cable warning.The issue occurred during an unknown therapeutic procedure.The procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
Correction: section d8 was answered ¿yes¿ for serviced by a third party when the device was not returned or evaluated to know this information.It was indicated by the customer that the device was not available for return to olympus for evaluation.Based on the evaluation of the information available, the broken cable damage was confirmed.The age-related wear in connection with repeated strong bending or tensile forces most likely lead to the broken cable.This causes a lack of electrical conductivity, which the generator displays with a corresponding error message.This report is also being supplemented to provide additional information based on the legal manufacturer's final investigation.Section h4 was updated with additional information that was received about the event.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 root cause is due to improper handling in connection with wear and tear overtime.This cause is attributed to bending the cable, winding it in a too small a radius or pulling on the cable instead of the plug.This can cause individual or all wires in the cable to break, which can lead to the issue described.Further, it was noted that the lot number cable in question was manufactured in october of 2020 and the cable has a limited use time period of 12 months, making the cable four years old.Countermeasures: according to the instructions for use (ifu) this cable has a use limit of 12 months to reduce the risk of this type of issue.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: HF-CABLE, MONOPOLAR
• 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: 19740759
• Report Number: 9610773-2024-01701
• Device Sequence Number: 7719709
• Product Code: HET
• UDI-Device Identifier: 04042761001557
• UDI-Public: 04042761001557
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K944200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: A0358
• Device Lot Number: 035952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2020
• 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