MAUDE Adverse Event Report: GYRUS ACMI, INC. HF-CABLE, MONOPOLAR; HI-Q HAND INSTRUMENTS

Model Number A0393

Device Problems Smoking (1585); Sparking (2595)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the hf-cable, monopolar had a spark at the base of the cable on the scalpel side, followed by smoke and sectioning of the cable.The event occurred during a therapeutic resection procedure.There was no patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the reportable malfunction was confirmed finding a cable is damaged/broken.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 of the reported event is unable to be determined.However, the cause of the event is likely due to age-related wear and tear in connection with improper handling.The event can be detected by following the instructions for use (ifu) which state: please note: to avoid this failure, oste recommends following the instructions in the ifu, which states that the service life of hf cables is restricted to one year.Furthermore, the cable must be inspected before and after each use and reprocessing cycle.This can be done by slightly pulling the plug to identify if wires inside the cable are pre-damaged (a force with 20 n at most shall be used when pulling the plug).When the cable remains rigid and does not bend, this area of the cable is very likely faultless.Additionally, the cable shall be wound up with a diameter of less than 10 cm.When removing the cable, the plug shall be pulled and not the cable.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Type of Device: HI-Q HAND INSTRUMENTS
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17931506
• MDR Text Key: 325630531
• Report Number: 3003790304-2023-00398
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A0393
• Device Lot Number: 127274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2021
• 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