MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-36K DISP PUNCH 3.6MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number	IPN915269
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint is confirmed, the punch has the tip stuck.However, it cannot be confirmed as a manufacturing defect since it is necessary to evaluate the sample involved on this complaint.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.If defective sample becomes available at a later date this complaint will be updated as applicable.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that during a renal transplant case performing an arterial anastomosis, "the punch got jammed.Scissors were used to cut around the punch to remove the device.The vessels were not calcified and the surgeon does not classify them as challenging cases".No report of patient harm or injury.The patient status is reported as "the patient is left with a densely fibrous anastomotic stricture which is difficult to manage".
Additional Manufacturer Narrative
(b)(4).One unit of catalog number dp-36k was received for evaluation.Sample wasn't received in its original packaging.The sample was visually inspected founding the tip stuck inside of blade.After force to release the tip, it was noticed tissue in the tip of core and inside of punch.No dimensional issues were found in blade.A functional inspection was not performed as part of this complaint evaluation since the sample was received stuck and the punch was broken to release the core.A device history record review was performed, and no relevant findings were identified.Even though the unit was stuck there is not sufficient evidence to assure this is a manufacturing defect, and it is unknown if instructions and warnings per ifu were properly followed.No dimensional issues were found therefore it cannot be confirmed as a manufacturing defect.Complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during a renal transplant case performing an arterial anastomosis, "the punch got jammed.Scissors were used to cut around the punch to remove the device.The vessels were not calcified and the surgeon does not classify them as challenging cases".No report of patient harm or injury.The patient status is reported as "the patient is left with a densely fibrous anastomotic stricture which is difficult to manage".

• Brand Name: PU DP-36K DISP PUNCH 3.6MM
• Common Device Name: 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19027725
• Report Number: 3004365956-2024-00029
• Device Sequence Number: 6992532
• Product Code: DWS
• UDI-Device Identifier: 14026704697936
• UDI-Public: 14026704697936
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: IPN915269
• Device Catalogue Number: DP-36K
• Device Lot Number: 74E2300126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown