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 10/12/2021

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 was misaligned during clipping on patient skin.Changed to a new clip.No patient harm reported.

Manufacturer Narrative

(b)(4).Per dhr 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.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# 73k210589 the staplers were functionally inspected and issue reported "misfire/jamming-misaligned staples" was not observed in the current manufacturing process, the staples were loaded and released correctly.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.

Event Description

The clip was misaligned during clipping on patient skin.Changed to a new clip.No patient 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12672602
• MDR Text Key: 277653019
• Report Number: 3003898360-2021-01004
• 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,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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: 73J1900168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2021
• 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: A
• Patient Sequence Number: 1