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

Model Number A0393

Device Problems Material Separation (1562); Arcing (2583); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation and the investigation is in process.The physical device evaluation has not yet been completed.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

An olympus representative reported that the subject device arced, the cap blew off the scope, and sparks flew.The intended procedure was an unspecified therapeutic procedure.There was no patient or user injury reported due to the event.Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.

Manufacturer Narrative

This supplemental report was submitted to provide the legal manufacturer¿s investigation results.The dhr review showed there is no non-conformity associated with this device with respect to the described issue and the device was manufactured according to valid instructions and met all specifications.The device was evaluation indicated the customer reported issue was not confirmed.However, the malfunction is a known error pattern.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.The cable was manufactured in march of 2018 which means that the cable is more than 4 years old.Therefore, the cable was used for longer than the specified 12 months.The cause of the reported issue is most likely due to wear and tear in connection with improper handling.As stated on the ifu (instructions for use manual) and as a preventative measure, the ifu states a suitable replacement device must be provided during an application.Additionally, the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.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 complaints for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Type of Device: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 15848042
• MDR Text Key: 306812742
• Report Number: 9610773-2022-00558
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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
• Device Operator: Health Professional
• Device Model Number: A0393
• Device Catalogue Number: A0393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1