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

Model Number	WA47706S
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	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, during a therapeutic hysteroscopy/myomectomy procedure using the loop cautery, the loop broke at the connection point to the electrode.The surgeon visualized the uterine cavity the entire time from the break to the retrieval and the loop itself was retrieved, intact, from the uterine cavity.There were no further foreign bodies visualized after the retrieval.The procedure was completed with another device.A fluoroscopy x-ray of the pelvis/uterine cavity was taken, followed by a flat p late x-ray at the conclusion of the procedure.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-00209.
Event or Problem Description
It was reported, the loop broke at the end of the procedure and was removed by trapping the wire with the end of the retractable loop arm without any cautery activated.Another surgeon then proceeded with the patient's breast surgery.There was no delay as the x-ray was done at the end of the completed cases, not in between.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information from the customer.This report has been submitted by the importer under this mdr report number 2429304-2024-00209-01.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and to provide an update to field h4.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, it was likely, that the reported event occurred, due to wear and tear.Additionally, the loop at the distal end of the electrode wears out, during use and may break, burn or melt.However, the subject device was not returned.And the root cause of the reported event could not be determined.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: 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, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18988746
• Report Number: 9610773-2024-00879
• Device Sequence Number: 18209006
• Product Code: FAS
• UDI-Device Identifier: 14042761085530
• UDI-Public: 14042761085530
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2024

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 Lot Number: 1100442429
• Was Device Available for Evaluation?: No
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/09/2024; 08/01/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/09/2024; 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White