MAUDE Adverse Event Report: COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	72203012
Medical Device Problem Codes	Material Fragmentation (1261); Intermittent Energy Output (4025)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the middle of a hysteroscopy myomectomy procedure, the shaver handpiece stopped working while being applied to the uterine wall.The handpiece was unplugged and replugged, after which it resumed functioning, but a humming noise was heard.The blade discharged metal shards into the cavity, and reminiscence of glitter particles (metal fragments) remained after resection.The metal fragments were not removed or retrieved after the case.The surgeon stated that it was okay to leave them inside cavity.No x-ray was performed to locate or confirm all pieces of the component.The foreign tissue was completely resected.

• Brand Name: TRUCLEAR
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23825992
• Report Number: 1282497-2025-00661
• Device Sequence Number: 5031895
• Product Code: HIH
• UDI-Device Identifier: 10884521744110
• UDI-Public: (01)10884521744110(11)230922(10)5595464
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: 5595464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 09/22/2023
• 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 Sex: Female