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

Model Number	080-401
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint description provided specified that the surgeon tried to release the punch while it was still engaged in the patient's aorta.This technique is incorrect as per the instructions for use for this device; the punch should not be released until after it is removed from the incision site.The ifu states "do not release the plunger" after activating the punch, and "keeping the plunger depressed, remove the punch from the incision area," and the warnings section states "after activation, do not release the plunger until the punch is removed from the incision site to prevent the excised tissue from being ejected into the surgical area or vessel interior." therefore, this incident seems to be related to improper use.The complainant also reported that they have continued to use other punches from the same lot # without incident.In addition, (b)(4) of the reported lot # have been distributed and no other issues have been reported on this lot from other customers.The device history record for this lot was reviewed and it did not indicate any manufacturing related issues, and production has not reported any in-process issues or seen any changes with manufacturing.Current punch production tests all punches for cut and activation prior to packaging.The suspect device was discarded and not returned to a&e for evaluation.Therefore, the information available suggests that this was an incident of misuse.Should additional information be provided, further investigation will be conducted.
Event or Problem Description
It was reported that the disposable aortic punch was engaged in the patient's aorta and it did not spring back open when he released his thumb.Dr.(b)(6) used one hand to stabilize the aorta and one hand to pull the punch open and it ripped out of the aorta tearing a piece off and the punch was still closed.It never released.The aorta had to be repaired with several sutures.

• Brand Name: ROTATING SURGICAL PUNCH
• Common Device Name: SURGICAL PUNCH
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: vashina shukla ; 5206 asbury road; farmingdale, NJ 07727 ; 7329387337
• MDR Report Key: 12824001
• Report Number: 2242056-2021-00008
• Device Sequence Number: 17227210
• Product Code: LRY
• UDI-Device Identifier: 10841291105183
• UDI-Public: (01)10841291105183(10)03881(17)260701
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2026
• Device Model Number: 080-401
• Device Lot Number: 03881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male