MAUDE Adverse Event Report: A&E MEDICAL CORPORATION ROTATING SURGICAL PUNCH

Model Number 080-401

Device Problems Failure to Cut (2587); Defective Device (2588); Insufficient Information (3190)

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

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

User-facility reported 3 units were not cutting cleanly.The suspect units were discarded and not returned to a&e.Investigation is ongoing.A follow-up report concluding the investigation will be issued.

Event Description

User-facility reported 3 units were not cutting cleanly.

Event Description

User-facility reported 3 units were not cutting cleanly.

Manufacturer Narrative

While the complaint units were not available for investigation, a&e completed a full investigation of the complaint.Summary of findings attached.Current punch production tests all punches for cut and activation prior to packaging.Conclusion was that the volume of punches sold and the very limited number of complaints, these failures are very isolated events.The complaint does not indicate a patient safety risk.The users continue to use the product and have not had subsequent cutting issues to date.Improvements to production process have been identified and will be implemented as stated in the report.This report closes the investigation and complaint.

• Brand Name: ROTATING SURGICAL PUNCH
• Type of Device: SURGICAL PUNCH
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale, nj
• MDR Report Key: 10217783
• MDR Text Key: 201218850
• Report Number: 2242056-2020-00003
• Device Sequence Number: 1
• Product Code: LRY
• UDI-Device Identifier: 10841291105169
• UDI-Public: (01)10841291105169(10)00097(17)241101
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 080-401
• Device Catalogue Number: 080-401
• Device Lot Number: 00551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention