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

Model Number WA00014A

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported that when using a high-frequency cable, bipolar, there was a spark from the connection between the wire and diathermy coil.The user then noticed that the wire had broken.The user assumed that this was from wear on the wire and exchanged the wire.The therapeutic procedure (hysteroscopic transcervical endometrial resection-tcer) was completed with a similar device.There was a second procedure with a different patient that day, and the same event from the previous occurred, but with a significantly larger spark and a smell.The user received a small burn mark on his hand, however; there was no medical treatment required.The wire had also broken again in the same place as before.The user then switched to a different device and cable to complete the procedure.There was no patient harm associated with the event.This report is for the patient 2 with the minor burn.The event for patient 1 is captured in the previously reported medwatch report with patient identifier (b)(6).

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, the root cause of the event could not be determined although it can be presumed it was due improper handling/excessive force, in combination with wear and tear.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: RESECTION AND VAPORIZATION ELECTRODE
• 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: 18177622
• MDR Text Key: 328629557
• Report Number: 9610773-2023-03352
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA00014A
• Device Lot Number: -
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2019
• 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