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

Model Number IPN028493

Device Problem Difficult to Open or Close (2921)

Patient Problems Scar Tissue (2060); Impaired Healing (2378)

Event Date 12/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Incident happened on the (b)(6) 2021.There was not a proper grip of staples as the staples were not applied well on the skin.Consequence: bad healing of the skin.

Event Description

Incident happened on the (b)(6) 2021.There was not a proper grip of staples as the staples were not applied well on the skin.Consequence: bad healing of the skin.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product visistat 35w 6/box lot # 73c2100575 was manufactured on 03/17/2021 a total of (b)(4) pieces.Lot was released on 04/26/2021.Dhr investigation did not show issues related to complaint.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.

• Brand Name: VISISTAT 35W 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13098029
• MDR Text Key: 283313948
• Report Number: 3003898360-2021-01131
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 14026704631787
• UDI-Public: 14026704631787
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028493
• Device Catalogue Number: 528235
• Device Lot Number: 73C2100575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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