MAUDE Adverse Event Report: HOLOGIC MYOSURE

Lot Number 731326

Device Problem Device Slipped (1584)

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

Event Date 03/16/2016

Event Type  malfunction  

Event Description

The inside portion of the myosure shaft came out when surgeon was using it.

• Brand Name: MYOSURE
• Type of Device: MYOSURE
• Manufacturer (Section D): HOLOGIC; marborough MA 01752
• MDR Report Key: 5570259
• MDR Text Key: 42518444
• Report Number: MW5061624
• Device Sequence Number: 1
• Product Code: HIH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/07/2016

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: Health Professional
• Device Lot Number: 731326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1