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

Model Number A0393

Device Problems Break (1069); Smoking (1585); Arcing (2583); Sparking (2595)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that towards the end of an unspecified orthopedic procedure of approx.Three hours, the hf cable emitted smoke and sparks and then broke.The intended procedure was completed using a similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

Corrected data: h4 - device manufacturer date.Device evaluation: the suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2021-09-27).The evaluation at omsc confirmed that the hf cable is broken near the connector for the generator, where the wires were found to be melted and charred.Furthermore, the outer side of the cable was found to be damaged near the plug for the instrument and the cable extended and stretched if pulled on the plug.This type of damage is usually caused by age-related wear and tear in connection with a repeated tensile/bending load.When the hf generator is activated, the broken wires may then cause voltage flashovers in the damaged area, which may result in the formation of sparks and the complete detachment of the connector.According to the article¿s lot number, the hf cable was manufactured in september 2019.It is therefore assumed that the hf cable was used longer than the 12 months the cable is designed for.Thus, this event/incident can most likely be attributed to age-related wear and tear in connection with improper handling by the customer and thus to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf cable without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF-CABLE, MONOPOLAR
• Type of Device: HF-CABLES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12511941
• MDR Text Key: 272659268
• Report Number: 9610773-2021-00262
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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
• Device Lot Number: 940767
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ERBE VIO 3 ELECTROSURGICAL UNIT; ERBE VIO 3 ELECTROSURGICAL UNIT