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

Model Number IPN028493

Device Problem Failure to Align (2522)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device history review for the product visistat 35w 6/box lot# 73d2100944 investigation did not show issues related to complaint.

Event Description

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

Event Description

On 16 mar 2022 staples were found jamming prior to the patient.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit of 528235 visistat 35w 6/box for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the first two staples appeared misaligned.The stapler was returned with 31 staples remaining in the cover block, indicating that at least 4 staples were fired by the customer.The trigger was returned partially engaged.Evidence of use in the form of biological material was present on the outside and inside of 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 two 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.Manual realignment of the staples was attempted; however, the staples still would not fire successfully.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 february 28, 2022.The returned sample was manufactured prior to these corrective actions.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." in summary, the reported complaint of "misfire/jamming - staples not firing" was confirmed based upon the sample received.Visual examination revealed that the first two staples appeared to be misaligned.Upon functional inspection, the misalignment of the staples prevented any staples from firing.The sample was disassembled, and no defects or anomalies were observed.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 february 28, 2022.The returned sample was manufactured prior to these corrective actions.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: 13955878
• MDR Text Key: 288684104
• Report Number: 3003898360-2022-00091
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 14026704631787
• UDI-Public: 14026704631787
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• 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: 73D2100944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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