MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35R 6/BOX; STAPLE, REMOVABLE (SKIN)

Model Number IPN028492

Device Problem Failure to Form Staple (2579)

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

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).From the pictures attached was unable to confirm failure mode reported as failure to function - other.However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause and implement corrective actions.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.P/n 528135 is not being manufactured currently, however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and was conducted as follows: 13 staplers were taken from the current production from p/n 528235 visistat 35w 6/box lot# 73f2100952 the staplers were functionally inspected and issue reported failure to function - other was not observed in the current manufacturing process, the staples were loaded and released correctly.The device history review for the product visistat 35r 6/box lot# 73j1900168 was manufactured on 09/09/2019 a total of 12,000 pieces.Lot was released on 09/23/2019.Dhr investigation did not show issues related to complaint.Failure mode failure to function - other could not be confirmed with picture received, however it is necessary to receive the physical sample to perform a proper investigation, determine root cause and implement corrective actions.

Event Description

The clip is improper closure to cause minor bleeding when pulling it.Patient has no harm reported.

• Brand Name: VISISTAT 35R 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 12181130
• MDR Text Key: 262256574
• Report Number: 3003898360-2021-00617
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 14026704631770
• UDI-Public: 14026704631770
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2021

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: IPN028492
• Device Catalogue Number: 528135
• Device Lot Number: 73J1900168
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• 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