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

Catalog Number 10-401

Device Problem Dull, Blunt (2407)

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

Event Date 11/24/2015

Event Type  malfunction  

Event Description

Blade was dull.

• Brand Name: MYOSURE TISSUE REMOVAL
• Type of Device: UTERINE TISSUE REMOVAL DEVICE
• Manufacturer (Section D): HOLOGIC INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 5350153
• MDR Text Key: 35240000
• Report Number: 5350153
• 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
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: 10-401
• Device Lot Number: 15F29R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2016
• 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: 63 YR