MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP"; RESECTION ELECTRODES WITH HF CABLE

Model Number	WA47706S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only part of the device was returned for evaluation, so the customer's allegation could not be confirmed at this time.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
An olympus representative reported on behalf of the customer, that a broken piece of a hf-resection electrode "plasmaloop", needed to be retrieved.The event occurred during the procedure and was completed with a similar device.There was no patient harm associated with the event.
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 to the reported issue.Based on the results of the investigation, root cause could not be identified although it can be presumed that it was caused by wear and tear.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP"
• Common Device Name: RESECTION ELECTRODES WITH HF CABLE
• 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: 17596845
• Report Number: 9610773-2023-02309
• Device Sequence Number: 7570196
• Product Code: FAS
• UDI-Device Identifier: 14042761085530
• UDI-Public: 14042761085530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: WA47706S
• Device Lot Number: 1000104667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown