MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22503D

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/14/2023

Event Type  Injury  

Event Description

The customer reported to olympus that during an intracavitary resection procedure, the resection electrode loop had been deformed and bent.A second one was used but broke and remained stuck in the patient's uterine polyp, which the customer was unable to recover.The patient had bleeding but recuperated afterwards.No prolonged hospitalization.The procedure was delayed for ten minutes and was not completed.The patient will have a new procedure - hysterectomy.The devices were inspected before use.There were no reports of further patient or user harm associated with this event.Two reports were required for this event with the following patient identifiers: (b)(6) - 1st resection electrode loop.(b)(6) - 2nd resection electrode loop.This report is for (b)(6).

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide a correction to the initial h3.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The complete evaluation results are as followed: the electrode is broken, and the wire ends are melted.The insulation sleeves show signs of thermal stress and/or are melted.The electrode wire and fork are deformed and/or no longer in their original position.The electrode contacts are metallic bright.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, it is likely that the suggested event occurred due to improper handling/excessive force by the user.It is possible to ignite plasma with a broken loop wire.Consequently, the user might still resect tissue until the damage at the distal end is identified visually.However, the root cause of the suggested event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• 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: 17914168
• MDR Text Key: 325412124
• Report Number: 9610773-2023-02877
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068205
• UDI-Public: 14042761068205
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22503D
• Device Lot Number: 1000083333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female