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

Model Number	7209807S
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 7209808s service control unit truclear (serial# (b)(6)) 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/polypectomy procedure for tissue removal, the handpiece became extremely hot and displayed an e6 error code.The device emitted a burning smell and was subsequently removed from the operating room, causing an hour delayed to the procedure.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.Another handpiece was used, and it worked fine.The procedure was completed as is with dilation and curettage (dc).
Additional Manufacturer Narrative
Correction: b5, h6 additional information: 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/polypectomy procedure for tissue removal, the handpiece became extremely hot, smoking and displayed an e6 error code.The device control unit emitted a burning smell and was subsequently removed from the operating room, causing an hour delayed to the procedure.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.Another handpiece was used, and it worked fine.The procedure was completed as is with dilation and curettage (d<(>&<)>c).
Event or Problem Description
It was reported that during a hysteroscopy/polypectomy procedure for tissue removal, the handpiece became extremely hot, smoking and displayed an e6 error code.The truclear control unit emitted a burning smell and was subsequently removed from the operating room, causing an hour delayed to the procedure.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.Another handpiece was used, and it worked fine.The procedure was completed as is with dilation and curettage (d<(>&<)>c).
Additional Manufacturer Narrative
Additional information: a1, b5, g3, d9, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the handpiece is not working and e6 error due to defective motor.The motor needs to be replaced to address the condition.It was reported that the handpiece became extremely hot, smoking and displayed an e6 error code.The truclear control unit emitted a burning smell.The reported issues were confirmed.The most likely cause was traced to component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21961078
• Report Number: 1282497-2025-00292
• Device Sequence Number: 12550657
• Product Code: HIH
• UDI-Device Identifier: 10884521749900
• UDI-Public: 10884521749900
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Followup
• Report Date (Section B): 08/17/2025

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: 7209807S
• Device Catalogue Number: 7209807S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 08/14/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/13/2025; 08/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: PLEASE SEE NOTE ON H11.
• Patient Sex: Female