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

Model Number A0393

Device Problems Sparking (2595); Noise, Audible (3273); Material Split, Cut or Torn (4008)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported cord split in half/popped/sparked.Per the report, the cord was being used with cautery with a resection scope.During the cautery, the cord popped, sparked, then split while in the surgeons hands.Patient was not injured.The surgeon was not injured either.A new cord was provided.In the voluntary mw report sent to olympus, it was reported "while having a resection of a bladder tumor, the electrocautery sparked and made a loud pop sound.This occurred outside of the patients body and no injury occurred to patient.The loop cautery cord and resection tray were all switched out as the cautery cord had sheared in half".No harm was reported.No user injury reported due to the event.

Manufacturer Narrative

The subject device was not returned for evaluation.The cause of the issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

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.Based on the results of the investigation, a definitive root cause of the reported broken and sparking high frequency cable issue could not be determined, however, the issue was likely the result of wear and tear, in combination with improper handling by the user.Based on the lot#, the cable was manufactured in april 2015 and was very likely used for more than 12 months.The event can be detected/prevented by following the instructions for use which state: ¿the service life of the cable is limited to 12 months.After this time, the cable should no longer be used¿.¿the cable must be checked for damage before each use and after processing.By gently pulling on the plug (max.20n) you can determine whether the copper strands of the cable are damaged.If the cable does not give way, but remains rigid, the cable is most likely ok at this point¿.¿in order not to further shorten the service life of the cable, the cable should not be coiled with a loop diameter of less than 10cm, and when unplugging the cable, pull the plug and not the cable¿.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Type of Device: HF-CABLE, MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 16844813
• MDR Text Key: 314297286
• Report Number: 9610773-2023-01180
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• 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: 515702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• 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
• Treatment: SCOPE.RESECTION TRAY.