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

Model Number A0393

Device Problems Melted (1385); Smoking (1585); Sparking (2595)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was discarded, however, pictures of the device shows the cable below the protective boot cover at male connector side is damaged and completely separated.The investigation is still ongoing; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

Event Description

The olympus sales representative reported the customer high-frequency monopolar cable had ¿sparked, melted and there was smoke¿.The customer reported event was found occurred during a transurethral resection of bladder tumor.The intended procedure was completed using another cable.There was a 5-minute delay and no additional anesthesia or sedation was required.The device was inspected prior to use but no anomalies were reported.No death or injury and no impact to patient or other has been reported to olympus.No device has been disposed by the customer following the procedure and will not be returned.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely the cable sparks/melts/smokes occurred due to wear and tear, in combination with improper handling.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance 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: 16294692
• MDR Text Key: 308915282
• Report Number: 9610773-2023-00415
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• 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: 012999
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• 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