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

Model Number	WA00013A
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received to date.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus during preparation for a therapeutic procedure, sparks were present when the hf-cable was connected to the ues-40.Upon reconnecting, the device did not power on.The procedure was completed using a similar device.There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to update d8/d9.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 could not be determined as the device was not returned for evaluation.It is likely age-related wear from repeated bending and/or tensile stress caused the wires in the cable to break.When the generator was then activated, it caused a voltage flashover at the damaged area and resulted in a spark.This is a known issue and in order to reduce the risk of this error, the service life of the cable was limited to 12 months.Therefore, the cause of the damage is most likely age-related wear associated with improper handling.To avoid such incidents, the instructions found in the instructions for use (ifu) should be followed.The service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Furthermore, the cable must be checked for damage before each use and after processing.By gently pulling on the plug (max.20n) you can determine whether the copper strands of the cable are damaged.If the cable does not give way, but remains rigid, the cable is most likely ok at this point.In order not to further shorten the life of the cable, the cable should not be coiled with a loop diameter of less than 10cm, and when unplugging the cable, pull the plug and not the cable.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE
• Common Device Name: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION 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, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15802271
• Report Number: 9610773-2022-00535
• Device Sequence Number: 5528720
• Product Code: FAS
• UDI-Device Identifier: 04042761030489
• UDI-Public: 04042761030489
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K100275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: WA00013A
• Device Catalogue Number: WA00013A
• Device Lot Number: 20Y06
• 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: 10/18/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS, MODEL UES-40.
• Patient Sex: Unknown