MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°

Model Number WA22503D

Device Problems Material Rupture (1546); Output Problem (3005)

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

Event Type  malfunction  

Event Description

It was reported that while using the high-frequency resection electrode during a hysteroscopy resection (patient under spinal anesthesia) therapeutic procedure, it was observed that there was a rupture to the terminal part of the single-use resection loop.The patient buttocks abruptly moved and she experienced pain without an error message being seen on the generator.The patient then complained of a metallic taste in her mouth.The procedure was stopped, and when the loop was removed, there was a rupture in the terminal part of the loop.There was no medical intervention required as a result of the reported device problem.

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

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 reported event is unable to be determined.However, the likely cause of the reported event is due to improper handling by the user.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°
• Type of Device: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18839143
• MDR Text Key: 337804243
• Report Number: 9610773-2024-00622
• 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: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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: WA22503D
• Device Lot Number: 100129771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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 Age: 46 YR
• Patient Sex: Female