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.
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.This report is being supplemented to provide additional information from the customer.

• 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
• MDR Report Key: 18988466
• Report Number: 2429304-2024-00209
• Device Sequence Number: 19575632
• Product Code: FAS
• UDI-Device Identifier: 14042761085530
• UDI-Public: 14042761085530
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024
• Report Date (Section F): 03/14/2024

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?: Yes
• Distributor Facility Aware Date: 03/14/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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