MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-44K DISP PUNCH 4.4MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number	IPN915271
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is reportedly not available for investigation.A visual nor functional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.The device history review could not be conducted since involved lot number was not provided.The customer complaint cannot be confirmed based only on the information provided; to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.If the sample becomes available this investigation will be updated with the evaluation results.
Event or Problem Description
While use in a cabg case the surgeon was using the aortic punch and the instrument was slightly jammed/stuck on the tissue of the aorta when closed.The surgeon was able to dislodge and open then punch with no harm but was concerned about its structure for future use.It has not happened in the last 2 months and may have been a certain box that was having this issue.They did not have the correct lot for these aortic punches used.They also told me they check and try the punches prior to use in a case.

• Brand Name: PU DP-44K DISP PUNCH 4.4MM
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12753858
• Report Number: 3004365956-2021-00302
• Device Sequence Number: 4557982
• Product Code: DWS
• UDI-Device Identifier: 14026704697950
• UDI-Public: 14026704697950
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN915271
• Device Catalogue Number: DP-44K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1