MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; ELECTRODE

Model Number WA00014A

Device Problem Sparking (2595)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

It was reported to olympus that an hf cable sparked during a tur-b procedure (resection of tumor in the bladder).It was reported that the doctor felt the heat from the spark and there was no burn.The procedure was completed with the same working element, but the cable was changed.There was no patient injury or adverse event reported to olympus.

Manufacturer Narrative

The device was returned to olympus.During their inspection, the sbc confirmed the reported issue.This is a known type of failure.In the course of time, one or more wires inside the cable can break due to permanent bending/tensile stress as well as wear and tear.When activating the generator, a voltage flashover at the damaged area might occur.This very likely causes a spark, and the plug becomes detached.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16710568
• MDR Text Key: 313202529
• Report Number: 9610773-2023-01012
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 193W-3508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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