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

Model Number A0357

Device Problem Arcing (2583)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus and a replacement device has been provided to the customer by the third-party distributor.The device history records (dhr) was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.Based on the error pattern, the cause of the damaged cable is potentially due to excessive mechanical stress during use.The cable was manufactured on january 5, 2021.As stated on the ifu (instructions for use manual) and as a preventative measure the ifu states, ¿using the hf cable after the restricted service life may cause electrical, mechanical and thermal injury.Signs of wear might not become visible.- do not use the hf cable after 12 months of use.- dispose of the hf cable after 12 months.¿ it can therefore be assumed that 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.Olympus will continue to monitor complaints for this device.

Event Description

The third party distributor reported to olympus; the customer monopolar high frequency cable was returned to the distributor for repair for a reported ¿contact failure¿ which was found during preparation for use.The distributor¿s inspection found the cable was burnt and broken which is likely attributed to internal wires being separated and caused arcing to occur.No death or injury and no impact to patient or other has been reported to olympus.This report is being submitted to capture the burnt and broken cable.

• Brand Name: HF-CABLE, MONOPOLAR
• Type of Device: HIGH FREQUENCY CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16594688
• MDR Text Key: 312299889
• Report Number: 9610773-2023-00842
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761001540
• UDI-Public: 04042761001540
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A0357
• Device Catalogue Number: A0357
• Device Lot Number: 050419
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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