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

Model Number 72204064

Device Problems Detachment of Device or Device Component (2907); Intermittent Energy Output (4025)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had an inner blade fracture.Functional testing found the device was disassembled to inspect the internal components.The inner blade had sheared off towards its proximal end, 346 mm from the helix.It was reported that the device stopped working unexpectedly during use.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, the two device's blades worked at first and then froze.The blades were replaced with another blade and the same thing happened.They then scoped up and used a different type of blade and completed the case.There was no patient injury.Initial evaluation of the incident found that the unit had an inner blade fracture.

• Brand Name: TRUCLEAR
• Type of Device: 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12178874
• MDR Text Key: 261896659
• Report Number: 1282497-2021-00036
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521744097
• UDI-Public: 10884521744097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2021
• Device Model Number: 72204064
• Device Catalogue Number: 72204064
• Device Lot Number: 4962746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1