MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°

Model Number	A22201C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device was not returned, the investigation is based solely on the information provided by the customer.Based on the investigation results, it was noted that in a hysterischoscopic monopolar procedure in the past, the distal end of the electrode broke and fell into the patient's body.The damage to the electrode remained undetected and the fragment of tungsten remained in the patient's uterus.There is no information about postoperative complications due to the whereabouts of the fracture fragment for a longer period of time (approximately 2 years).There is no information as to whether or when the wire fragment will be removed from the body.Based on the results of the investigation, it is likely that the following led to the event: wear and tear.The tip at the distal end wears out and may burn or melt if broken.Device can loose broken parts.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported that a patient previously underwent a hysteroscopic resection of the lesion; endometrial polyp and submucosal myoma resection on (b)(6) 2022 wherein the subject device was used.The procedure was completed without complications.Approximately two years later, at the patient's request, the user facility asked for detailed information on the materials from which the subject device was made as the patient had imaging examination that revealed a metal element in the uterus.The user facility indicated that they just wanted to exclude or confirm that this element found in the patient is part of the subject device.There were no reports of further patient harm.Additional information on patient outcome and further patient impact were requested but no further details were provided.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°
• Common Device Name: HF-RESECTION ELECTRODE
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20854407
• Report Number: 9610773-2024-02738
• Device Sequence Number: 15647574
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K954488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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: A22201C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Female