MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-52K DISP PUNCH 5.2MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number IPN056400

Device Problem Entrapment of Device (1212)

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

Event Date 06/24/2022

Event Type  malfunction  

Event Description

The blade did not make a 360 compliant cut on the iliac artery and at the same time the uncut flap got stuck in the mechanism, with the risk of a dissection of the arterial vessel necessary to carry out the graft of the kidney to be transplanted.The same event was reported on the contralateral artery.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Manufacturer Narrative

(b)(4).The device history record of batch number 74f2100126 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.No corrective action can be established at this moment since the product sample is not available for evaluation.Product sample is necessary to perform a proper investigation to determinate the root cause and the corresponding corrective actions.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 neither is being manufactured at the time.

Event Description

The blade did not make a 360 compliant cut on the iliac artery and at the same time the uncut flap got stuck in the mechanism, with the risk of a dissection of the arterial vessel necessary to carry out the graft graft of the kidney to be transplanted.The same event was reported on the contralateral artery.

• Brand Name: PU DP-52K DISP PUNCH 5.2MM
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15223765
• MDR Text Key: 305158564
• Report Number: 3004365956-2022-00056
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704714114
• UDI-Public: 14026704714114
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN056400
• Device Catalogue Number: DP-52K
• Device Lot Number: 74F2100126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.