MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number	WA22703S
Medical Device Problem Codes	Break (1069); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the electrode loop distal end melted during a transurethral resection of bladder neck procedure.The procedure was delayed 5 minutes and was completed with a similar device.A 5 minute delay is not significant.The patient condition was not affected by the failure and no medical intervention was required.There were no reports of harm.
Additional Manufacturer Narrative
The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue was confirmed.The device evaluation found that its shaft and the fork tubes were bent downward.There was a piece of unknown white plastic adhering on the cutting loop.The loop was severely bent, melted, and got stuck inside the white plastic due to thermal damage, but no charred marks observed on the distal insulation tubes.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Medical device problem code was corrected to be "1385 - melted." additional information added to fields: g2, h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 years since the subject device was manufactured.Based on the results of the investigation, it is likely due to the fused loop caused by improper handling of the affective device by the user and the deformed electrode by a strong mechanic impact/ the use of excessive force on the affected device.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• 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: 17666422
• Report Number: 9610773-2023-02416
• Device Sequence Number: 6228821
• Product Code: FAS
• UDI-Device Identifier: 14042761085332
• UDI-Public: 14042761085332
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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 Expiration Date: 01/23/2026
• Device Model Number: WA22703S
• Device Lot Number: 1000114155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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