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

Model Number 72204064

Device Problems Difficult to Remove (1528); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2020

Event Type  malfunction  

Event Description

Truclear dense tissue shaver mini handpiece was opened to the sterile field.As the tech was removed from the package, a small piece fell out of the attachment end of the device.The device would not operate without the piece, so another was opened.This new device was completely intact upon opening which leads us to think that the first device was not operational or correctly assembled.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9711011
• MDR Text Key: 179421003
• Report Number: 9711011
• 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: 01/27/2020

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: No Information
• Device Model Number: 72204064
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14600 DA