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

Model Number	7209820
Medical Device Problem Codes	Fail-Safe Problem (2936); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 72203012, dense tis shaver plus 72203012 truclear (lot#:unknown), 7209807, 7209807 truclear handpiece (serial#:unknown), 7209808, 7209808 truclear control unit (serial#:unknown).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 a hysteroscopy and myomectomy procedure, the dense tis shaver plus experienced a failure of the window lock feature after inserting the blade into the back of the scope when in the uterus.This issue led to unanticipated tissue loss.The blade did not come pre-window locked, and attempts to lock it with the foot pedal were unsuccessful as it would fall out of window lock during resection.There was no issue with handpiece.To resolve the issue and complete the procedure, suction was manually turned on and off to ensure it was only active during resection.No additional operation was planned to correct the issue.
Additional Manufacturer Narrative
Additional information: b5, g3.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 a hysteroscopy and myomectomy procedure, the dense tis shaver plus experienced a failure of the window lock feature after inserting the blade into the back of the scope when in the uterus.This issue led to unanticipated tissue loss.The blade did not come pre-window locked, and attempts to lock it with the foot pedal were unsuccessful as it would fall out of window lock during resection.There was no issue with handpiece.To resolve the issue and complete the procedure, suction was manually turned on and off to ensure it was only active during resection.The surgeon continued to use the dense tissue shaver (dtsp), although they had to manually turn on and off the suction to maintain distention a visualization.No additional operation was planned to correct the issue.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21503897
• Report Number: 1282497-2025-00109
• Device Sequence Number: 17268405
• Product Code: HIH
• UDI-Device Identifier: 10884521749948
• UDI-Public: 10884521749948
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 7209820
• Device Catalogue Number: 7209820
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Female