MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM; INSTRUMENTS,SURGICAL,CARDIOVASCULAR

Catalog Number DP-40K

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection report was originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to our specifications.The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The surgeon used the punch on the renal artery but the punch did not release.The surgeon cut around the product to remove it for the artery.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).Visual inspection was performed to 4 pieces from product code dp-40k received as part of this complaint, one of the pieces looks used and contains remains of blood on tip of product, the rest of pieces are closed and complete.The open piece it was received stuck and it is not able to operate due the condition mentioned.Dimensional tests according to qa-pun-001/f2 & f3 were performed obtained acceptable results in core and blade parts.These tests were performed to the 3 closed pieces; for the fourth piece was not possible to perform the dimensional inspection due the stuck condition the blade and core were not able to disassembly to be measure.As additional document revision the instructions for use 151894mx applicable to product code dp-40k was reviewed and as part of warnings on this document the following indication is placed: "remove the excised tissue before additional openings are created".This warning avoids a functional failure in dispositive provoked by blood residues and tissue.No corrective actions can be established since the dimensional and functional test demonstrated that other remarks: products are according to specification also according to ifu 151894mx a product should be cleaned before additional openings are created but based in open sample received the complete cut area contains remains of blood.The dhr reviewed showed that there were no issues related to the reported failure mode neither on the product or its components during the manufacture of this material.Closed samples received demonstrated are according to specifications although the condition reported is observed on open sample (jammed punch).This customer complain cannot be confirmed based in open sample condition that indicates that product was not used properly according to warnings in ifu 151894mx.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

Event Description

The surgeon used the punch on the renal artery but the punch did not release.The surgeon cut around the product to remove it for the artery.The patient's condition was reported as unknown.

• Brand Name: PU DP-40K DISP PUNCH 4.0MM
• Type of Device: INSTRUMENTS,SURGICAL,CARDIOVASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park 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: 6264818
• MDR Text Key: 65347399
• Report Number: 3004365956-2017-00037
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2021
• Device Catalogue Number: DP-40K
• Device Lot Number: 74G1600720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• 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
• Patient Outcome(s): Required Intervention