MAUDE Adverse Event Report: HOLOGIC MYOSURE REACH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 10-401FC

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2021

Event Type  malfunction  

Event Description

Reprocessed myosure reach removal device opened for use in a procedure.The tip of the instrument was found to be bent and unusable.The item was removed from the room.Another instrument was opened and used.Fda safety report id # (b)(4).

• Brand Name: MYOSURE REACH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC; marlborough MA 01752
• MDR Report Key: 12828450
• MDR Text Key: 281006247
• Report Number: MW5105368
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/12/2021

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 Model Number: 10-401FC
• Device Lot Number: 13161943
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female