MAUDE Adverse Event Report: WIRE COLLET; ARTHROSCOPE

Model Number 4100062000

Device Problem Overheating of Device (1437)

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

Event Date 09/29/2021

Event Type  malfunction  

Event Description

The user facility reported that the device overheated during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Correction: d9, h3 additional info h6 h3 other text : device not accessible for testing.

Event Description

The user facility reported that the device overheated during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: WIRE COLLET
• Type of Device: ARTHROSCOPE
• MDR Report Key: 12652184
• MDR Text Key: 277346164
• Report Number: 0001811755-2021-00797
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068354
• UDI-Public: 04546540068354
• Combination Product (y/n): N
• PMA/PMN Number: K112593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4100062000
• Device Catalogue Number: 4100062000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1