MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; HI-Q HAND INSTRUMENTS- UROLOGY

Model Number A0393

Device Problems Smoking (1585); Sparking (2595)

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

Event Date 01/10/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event by the customer, during a therapeutic transurethral resection of the prostate (turp) procedure, when the monopolar technology was ignited, the device sparked and there was a bit of smoke.The cord detached from the end plugging into the generator.There was no harm or adverse impact to the patient.There was no impact to the outcome of the procedure.Procedure was completed with the same device.Some other unknown device was replaced.The non-olympus generator settings were at default.The device has reused more than 10 times.

Event Description

Addendum (b)(6) 2022: the procedure was completed with another device of the same model number without any issues.

Manufacturer Narrative

Additional information has been received from the customer.This supplemental report is being submitted to provide this information.The device was inspected before use with no anomalies noted.

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, therefore, it is likely that the cable was used for longer than the specified 12 months.Based on the results of the investigation, it is very likely that the age-related wear in connection with repeated extreme bending or tensile loads most likely led to the breakage of single or all the wires in the cable.This can cause a voltage spike at the damaged area when the generator is activated which may result in a spark and complete disconnection of the plug.The specific cause of the cable sparking was likely due to age-related wear in connection with improper handling.The service life of the cable is limited to 12 months.After this time, the cable should no longer be used.The following information is stated in the instructions for use regarding proper handling of the device: "additionally, the cable must be checked for damage before each use and after reprocessing.By gently pulling on the plug (max.20nm), it can be determined whether the copper strand of the cable is already damaged.If the cable does not give way but remains rigid, the cable is most likely intact.In order not to shorten the service life of the cable any further, the cable should not be wound up with a loop diameter of less than 10cm and when pulling out the cable, the plug should 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- UROLOGY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 13421998
• MDR Text Key: 284856066
• Report Number: 9610773-2022-00070
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• 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: 832580
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2018
• 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: CLV 190.ESG 400.WA2T430A.CH-S190-08-LB (SN 7603425; ERBE GENERATOR.