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

Model Number IPN915271

Device Problem Mechanical Jam (2983)

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

Event Date 08/19/2021

Event Type  malfunction  

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 Description

Note: this report represents other customer device reports with unknown details but reported as a similar event to the report below.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
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 12753916
• MDR Text Key: 280260298
• Report Number: 3004365956-2021-00303
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704697950
• UDI-Public: 14026704697950
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: IPN915271
• Device Catalogue Number: DP-44K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1