MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE; MYOSURE TISSUE REMOVAL DEVICE

Catalog Number 50-401XL

Device Problem Device Inoperable (1663)

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

Event Date 04/22/2015

Event Type  malfunction  

Event Description

The surgeon was using the device when it suddenly stopped working.

• Brand Name: MYOSURE
• Type of Device: MYOSURE TISSUE REMOVAL DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 35 crosby drive; bedford, MA 01730
• MDR Report Key: 5103670
• MDR Text Key: 26730533
• Report Number: 5103670
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: 50-401XL
• Device Lot Number: 14G22RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR