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

Catalog Number 528235

Device Problem Failure to Align (2522)

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

Event Date 03/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product visistat 35w 6/box lot# 73j2000387 investigation did not show issues related to the complaint.

Event Description

On (b)(6) 2022, staples were found jamming prior to the patient.

Event Description

07 mar 2022 staples were found jamming prior to the patient.

Manufacturer Narrative

(b)(4).The customer returned one unit of 528235 visistat 35w 6/box for investigation.The returned sample was visually examined with and wi thout magnification.Visual examination of the returned sample revealed that the first four staples appeared misaligned.The stapler was returned with 38 staples remaining in the cover block.The trigger was returned partially engaged.Signs of use in the form of biological material was present on the device.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon engagement of the trigger, no staple fired.Multiple attempts were made, but no staples fired.It appeared that the misalignment of the first four staples was preventing the staples from moving down the track and into the forming tool.The stapler was disassembled, and it was confirmed to have been assembled correctly.No defects or anomalies were observed with the device.It could not be determined what exactly caused the first four staples to misalign.The returned sample was manufactured prior to the corrective actions implemented to address this issue in a nonconformance.The ifu for this product, l02644, was reviewed as a part of this complaint investigation.The ifu states, "to obtain optimum staple closure, the trigger must be squeezed all the way in." it could not be determined what caused the staples to misalign.Several actions to mitigate defects for this issue were established as part of a nonconformance, which was closed on (b)(6) 2022.The returned sample was manufactured prior to these corrective actions.The reported complaint of "misfire/jamming - staples not firing" was confirmed based upon the sample received.Visual examination revealed that the first four staples appeared to be misaligned.Upon functional inspection, the misalignment of the staples prevented any staples from firing.The sample was disassembled, and an excess buildup of biological material was observed in the device.No other defects or anomalies were observed.It could not be determined what caused the staples to misalign.The returned sample was manufactured prior to the corrective actions implemented to address this issue in a nonconformance.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: 13903020
• MDR Text Key: 287912399
• Report Number: 3003898360-2022-00086
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 528235
• Device Lot Number: 73J2000387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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