MAUDE Adverse Event Report: TENOTOMY

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/03/2017

Event Type  malfunction  

Event Description

Scissors tip broke during procedure; fragment retrieved.

• Brand Name: TENOTOMY
• Type of Device: TENOTOMY
• MDR Report Key: 6954723
• MDR Text Key: 89624733
• Report Number: MW5072794
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1