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

Model Number 72204878

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the outer tube was dented, kinked, had distal tip damage, the light post body was damaged, and the laser welded seam was cracked.The evaluation found the illumination fibers were broken and the illumination was low.There were particulates under distal lens and cosmetic eyepiece damage.It was reported that the scope of the device was damaged.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, prior to use, the device had a damaged tip.There was no patient involvement.

• 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10777652
• MDR Text Key: 214356980
• Report Number: 1282497-2020-00046
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521746633
• UDI-Public: 10884521746633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204878
• Device Catalogue Number: 72204878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1