MAUDE Adverse Event Report: HOLOGIC; MYOSURE REACH

Catalog Number 10403FC

Device Problems Failure to Cut (2587); Intermittent Energy Output (4025)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

Reprocessed myosure stopped cuttiing midcase x 2each.

• Type of Device: MYOSURE REACH
• Manufacturer (Section D): HOLOGIC; 250 campus dr; marlborough MA 01752
• MDR Report Key: 17162096
• MDR Text Key: 317466982
• Report Number: 17162096
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2023

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 Catalogue Number: 10403FC
• Device Lot Number: 14167438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Sex: Female