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

Model Number IPN028492

Device Problem Failure to Align (2522)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The clip is misaligned during use.

Event Description

The clip is misaligned during use.

Manufacturer Narrative

(b)(4).Per dhr the product visistat 35r 6/box lot # 73l2000558 was manufactured on 11/24/2020 a total of (b)(4) pieces.Lot was released on 12/04/2020.Dhr investigation did not show issues related to complaint.Revision of fmea-08-028 rev 05 was performed and the failure mode is already including it, no update is required.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 35R 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12569784
• MDR Text Key: 274566722
• Report Number: 3003898360-2021-00961
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 14026704631770
• UDI-Public: 14026704631770
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1