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

Model Number	72203012
Medical Device Problem Codes	Failure to Cut (2587); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hysteroscopy polypectomy the soft tissue shaver was not dissecting properly, appeared slow, and seemed blunt.The dense tissue shaver plus was then used, but the situation did not improve.A reusable hand instrument was also tried, resulting in only a very slight improvement.The polyp being removed was over 3 cm in size.Due to the performance of the devices, the procedure had to be completed using bipolar resection, which was not initially available in the hospital.This switch extended the surgical time by one hour.
Additional Manufacturer Narrative
D10 concomitant products: 7209509, soft tissue shaver plus 7209509 truclear (lot#:5832568), 7209808, 7209808 truclear control unit (serial#: (b)(6)), 7209807, 7209807 truclear handpiece (serial#: (b)(6)), 72205000, control unit 72205000 hysterolux (serial#: (b)(6)), 72205051, hysteroscope seal 72205051 truclear (lot#:9767402) 72205015, procedure kit 72205015 hysterolux (lot#:w5g0126).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.
Additional Manufacturer Narrative
Correction: h6 (removed rfr: adverse event) additional information: g3 additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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.

• 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: 24244715
• Report Number: 1282497-2026-00008
• Device Sequence Number: 8308979
• Product Code: HIH
• UDI-Device Identifier: 10884521744110
• UDI-Public: (01)10884521744110(17)280108(10)5775673(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: 5775673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/06/2026
• Date Device Manufactured: 01/08/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female