MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE

Model Number	WA47706S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus during a hysteroscopy myomectomy (resection of a uterine fibroid) the loop broke.The loop broke completely off the electrode and was lost in the uterus for approximately 5-10 minutes.It was located and removed using a 5.5mm hysteroscope and graspers.A 2nd loop was used to complete the procedure.The customer reported "several broken loops previously." a request for additional information in progress.
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer provided additional information: doctor confirmed the loop was retrieved in the case.The case finished as the doctor had hoped and the patient was planning to go home from the hospital same day.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: the electrode loop of the "plasma loop" broke off in its entirety.In this respect, the damage was caused by forcible breakage which was preceded by deformation of the loop.The ends of the wires in the fork are repositioned in one direction.In addition, no burn marks are visible and there is contamination at the proximal end.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 1 year since the subject device was manufactured.Based on the results of the investigation, the reported event likely occurred due to an application of excessive force and improper handling.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; JA 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15555901
• Report Number: 9610773-2022-00461
• Device Sequence Number: 5861683
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA47706S
• Device Catalogue Number: WA47706S
• Device Lot Number: 1100363105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 10/07/2022; 03/02/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/04/2022; 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ESG-400; UNKNOWN ENDOSCOPE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown