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

Model Number 72202536

Device Problem Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

Truclear mini shaver was shaving the tissue but unable to suction out any of the fluid or tissue.We swapped out the handpiece multiple times and still had the same issue when we realized it was the actual shaver.The rep was called and made aware.Manufacturer response for mini shaver, truclear soft tissue shaver mini (per site reporter).They were just notified yesterday.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 12 gill street, suite 3500; woburn MA 01801
• MDR Report Key: 16263628
• MDR Text Key: 308385999
• Report Number: 16263628
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202536
• Device Catalogue Number: 72202536
• Device Lot Number: 5446856
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Female
• Patient Race: White