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

Model Number	7209808
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 7209808, 7209808 truclear control unit (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 the procedure, the control unit had an error 6 that was why the handpiece/foot pedal failed to work.They tried plugging in numerous handpieces and changing blades but the issue persisted.They were unable to complete the procedure and the patient was already under anesthesia, therefore, there was a delay to the prescribed treatment for the patient.The procedure was completed by doing a manual polypectomy.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (fdr - c02).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 procedure, the control unit had an error 6 that is why the handpiece/foot pedal failed to work.They tried plugging in numerous handpieces and changing blades but the issue persisted.They were unable to complete the initial procedure and the patient was already under anesthesia.The procedure was completed by doing a manual polypectomy and had a five minute delay.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the unit found no damages.The device was connected to external power and was powered on.A test handpiece (cl-15165) and footswitch were connected to the control unit.When the footswitch was pressed, the handpiece did not activate and the control unit displayed the customer stated error e6.The device was power cycled and tested multiple times with the same result.The device was opened and inspected.Root cause was isolated to a zenner diode z6, measuring with a fluke dmm (cl-14290) found the zenner diode had internally shorted.The component was replaced with a test component.It was reported that the control unit had an error 6, which is why the handpiece/foot pedal failed to work.The reported issue was confirmed.The most likely cause could not be established from the information available.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.
Additional Manufacturer Narrative
Correction: h3 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the unit found no damages.The device was connected to external power and was powered on.A test handpiece (cl-15165) and footswitch were connected to the control unit.When the footswitch was pressed, the handpiece did not activate and the control unit displayed the customer stated error e6.The device was power cycled and tested multiple times with the same result.The device was opened and inspected.Root cause was isolated to a zenner diode z6, measuring with a fluke dmm (cl-14290) found the zenner diode had internally shorted.The component was replaced with a test component.It was reported that the control unit had an error 6, which is why the handpiece/foot pedal failed to work.The reported issue was 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22714879
• Report Number: 1282497-2025-00531
• Device Sequence Number: 9583448
• Product Code: HIH
• UDI-Device Identifier: 10884521749931
• UDI-Public: 10884521749931
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031787
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2025

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: 7209808
• Device Catalogue Number: 7209808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 08/18/2025; 08/18/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/18/2025; 08/19/2025; 08/19/2025
• 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
• Patient Age: 68 YR
• Patient Sex: Unknown
• Patient Weight: 67 KG