MAUDE Adverse Event Report: HOLOGIC MYOSURE; MYOSURE XL

Catalog Number 50-501XL

Device Problems Break (1069); Component Falling (1105)

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

Event Date 07/24/2017

Event Type  malfunction  

Event Description

The myosure xl device stopped working.On inspection, the resector looked like it fell into the device, or a piece was missing.The attending surgeon tried to pull up the resection with a kelly clamp to see it, it just dropped.The resector would just break on each attempt.

• Brand Name: MYOSURE
• Type of Device: MYOSURE XL
• Manufacturer (Section D): HOLOGIC
• MDR Report Key: 6830524
• MDR Text Key: 84076718
• Report Number: MW5071837
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/25/2017

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 Expiration Date: 03/24/2020
• Device Catalogue Number: 50-501XL
• Device Lot Number: 17C24RF
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR