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

Model Number IPN056400

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.The device history record of batch number 74f2001457 that belong to catalog number dp-52k has been reviewed and no issues or discrepancies were found which could potentially be related 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 and inspected according to our specifications.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during use on a patient the surgeon observed that the system remained blocked in close position with a piece stuck in it.Additional information: the patient is fine, no injury or clinical consequences, no medical intervention required.

Event Description

It was reported that during use on a patient the surgeon observed that the system remained blocked in close position with a piece stuck in it.Additional information: the patient is fine, no injury or clinical consequences, no medical intervention required.

Manufacturer Narrative

(b)(4).One unit of catalog number dp-52k (pu dp-52k disp punch 5.2mm)was received for analysis without its original packaging nor green cap.No block issues were observed.Sample had a desisfection tag.Punch was actuated, and no jamming nor block issues were found as the complaint description says.No gap between the core and blade was observed.The ifu l02984 r00 contain some warnings about the care and proper use of product: removed the excised tissue before additional openings are created./ failure to remove excised tissue from th epunch or excessive cleaning may cause punch jamming or incomplete cuts.No corrective action can be established since no problem found on sample.Customer complaint cannot be confirmed since no problem found on sample.Sample was actuated, and no jamming nor block issues were found as the complaint description says.

• Brand Name: PU DP-52K DISP PUNCH 5.2MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10704688
• MDR Text Key: 213696377
• Report Number: 3004365956-2020-00209
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

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 Expiration Date: 06/29/2022
• Device Model Number: IPN056400
• Device Catalogue Number: DP-52K
• Device Lot Number: 74F2001457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1