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

Model Number	A0393
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported that the monopolar cable made a popping noise and could no longer be used in the procedure.There were no reports of harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: b5, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over nine(9) years since the subject device was manufactured.The device was not returned to olympus for inspection, and the customer's reportable malfunction was not confirmed.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.Based on the results of the investigation the root cause could not be identified;however it is likely that the cable may be damaged by strong mechanical stress occurring from regular use, for example by kinking the cable, winding it in a radius that is too small or by pulling on the cable instead of the plug.This may cause individual or all wires in the cable to break.The event can be prevented by following the instructions for use which state: 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 field performance for this device.
Event or Problem Description
The customer reported that the procedure was therapeutic.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: HF-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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18120010
• Report Number: 9610773-2023-03257
• Device Sequence Number: 6988170
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 439673
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• 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