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

Model Number	A22201C
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer returned the referenced electrode loop (lot 1000081151) for evaluation due to "loop broke while in use".The user's complaint of the loop breaking, has been confirmed.The device was not returned in the original package.A visual inspection on the received condition was performed and noted the loop was broken, and split.The broken and split loop at the distal end side is missing a portion, which was not returned for evaluation.Approximately 40 percent of the electrode loop missing.The yellow insulation leading up to the loop has thermal damage (melted), and missing pieces as well.Additional findings include, thermal damage, charring at the proximal end.The device could not be functionally tested, due to the condition of the electrode loop.Additional information has been requested from the user facility for the reported event.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer care representative was informed by the user facility that the customer single use high frequency resection electrode, loop failed during use.The ¿loop broke while in use.No pieces were left in the patient.¿ no death or serious injury was reported to olympus.The electrode will be returned for evaluation.
Additional 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 the electrode loop that broke during use.A definitive root cause for this issue was not established.However, it is probable that the issue occurred due to mishandling or due to wear and tear.The loop at the distal end of the electrode wears out during use and may break, burn, or melt.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR.
• Common Device Name: HF-RESECTION ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14366220
• Report Number: 9610773-2022-00166
• Device Sequence Number: 12175724
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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
• Operator of Device: Health Professional
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: 1000081151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown