MAUDE Adverse Event Report: HOLOGIC MYOSURE TISSUE REMOVAL DEVICE

Model Number 10-401

Device Problems Material Fragmentation (1261); Device Inoperable (1663); Noise, Audible (3273)

Patient Problem Tissue Damage (2104)

Event Date 08/26/2015

Event Type  Injury  

Event Description

During the use of myosure tissue extraction device it had a malfunction and stopped working.It made a loud noise.It was replaced with another myosure device.At the end of the procedure there were small metal flecks on the fundus so a sharpe d and c had to be performed and copious irrigation.A kub of the abdomen and pelvis was done in the recovery room to determine if there was any residual.It was negative.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• Type of Device: MYOSURE TISSUE REMOVAL DEVICE
• Manufacturer (Section D): HOLOGIC; malborough MA 01752
• MDR Report Key: 5077539
• MDR Text Key: 25890087
• Report Number: MW5056133
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2015

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: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: 10-401
• Device Lot Number: 15C16RF
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 66