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

Model Number 72202536

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2023

Event Type  malfunction  

Event Description

Truclear soft tissue shaver mini ¿ uterine polyp shaver.Tissue and fluid would not pass through shaver.Suction and hand piece were both fully functioning.Manufacturer response for uterine shaver, truclear soft tissue shaver mini -uterine polyp shaver (per site reporter).The device was just picked up [redacted date].

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 12 gill street, suite 3500; woburn MA 01801
• MDR Report Key: 16263692
• MDR Text Key: 308386050
• Report Number: 16263692
• 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: 01/18/2023,01/17/2023

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 Lot Number: S432087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2023
• Event Location: Hospital
• 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: 18250 DA
• Patient Sex: Female