MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR.

Model Number A22251C

Device Problems Melted (1385); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has returned to olympus for evaluation.Preliminary findings are reported.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the user's report is confirmed.The received device was not returned in the original packaging.Olympus performed a visual inspection on the received condition of the electrode and found the loop at the distal end charred, broken, and missing the roller component.The insulation covering on both sides of the distal tip appear to be melted, charred, and exposing metal wire, which is signs of use and thermal damage.The shaft portion leading up to the proximal end, appears normal.Additionally, the proximal end has normal wear.The lot number is present on the device.Olympus was unable to functionally test the electrode due to the damage.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during an ablation resection in the uterus using a hf-resection electrode (roller), the rollerball tip broke, burnt out and became damaged.The procedure was completed.The issue with the device did not impact the outcome of the procedure.X-ray performed after the procedure showed the device fragment remains inside the patient.No additional consequences to the patient have been reported.Additional details regarding the patient and event were requested from the customer with no response.

Manufacturer Narrative

This report is being updated to provide investigation results.New information is reported in h4, h6, and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Conclusion: : a broken electrode wire of a roller electrode is a known error pattern and can most likely be traced back to the use of excessive force, use-related wear and tear, and/or wrong handling.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR.
• Type of Device: HF-RESECTION ELECTRODE, ROLLER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11314428
• MDR Text Key: 234930743
• Report Number: 9610773-2021-00073
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036815
• UDI-Public: 14042761036815
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22251C
• Device Catalogue Number: A22251C
• Device Lot Number: 1000057255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other