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

Model Number IPN028493

Device Problem Failure to Form Staple (2579)

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

Event Date 01/24/2022

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

The staples were not properly formed so that the user could not staple during procedure.Therefore, a new unit was used instead.

Manufacturer Narrative

Qn#: (b)(4).The lot number was not reported, but two potential lot numbers were found by looking at the sales history.The potential lot numbers are 73d2100944 and 73d2100779.A dhr was performed on both potential lot numbers.Per dhr the product visistat 35w 6/box lot # 73d2100944 was manufactured on 04/30/2021 a total of (b)(4) pieces.Lot was released on 05/21/2021.Dhr investigation did not show issues related to complaint.Per dhr the product visistat 35w 6/box lot # 73d2100779 was manufactured on 04/26/2021 a total of (b)(4) pieces.Lot was released on 05/13/2021.Dhr investigation did not show issues related to complaint.The customer returned one unit 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 sample was returned with its trigger partially engaged.The staples appeared to be properly aligned.Additionally, 11 staples were returned loose.Four of the loose staples were formed properly, but the other seven were unformed.The stapler was returned with 21 staples left in the cover block, indicating that at least 14 staples were fired by the end user, including the loose staples.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon engagement of the trigger, the first staple was able to properly fire from the device.This was repeated two more times with the same result.To simulate skin insertion, the stapler was fired into a simulated skin pad.The next 10 staples were fired into the simulated skin pad.There were 8 successful attempts, but 2 staples were unable to form when fired.The stapler was disassembled, and it was confirmed to have been assembled correctly.No other defects or anomalies were observed with the device.It could not be determined what prevented some staples from forming properly.A nonconformance has been opened by the manufacturing site to further investigate visistat jamming issues.It could not be determined what prevented some staples from properly forming when fired.A nonconformance has been opened by the manufacturing site to further investigate this visistat jamming issue.The reported complaint of "misfire/jam-staples not forming/closing" was confirmed based upon the sample received.Upon functional inspection, 2 staples were unable to properly form when fired out of the 13 staples that were tested.The sample was disassembled , and no other defects or anomalies were observed.It could not be determined what prevented some staples from forming properly.A nonconformance has been opened by the manufacturing site to further investigate visistat jamming issues.

Event Description

The staples were not properly formed so that the user could not staple during procedure.Therefore, a new unit was used instead.

• 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: 13344375
• MDR Text Key: 284378739
• Report Number: 3003898360-2022-00024
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 14026704631787
• UDI-Public: 14026704631787
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: N/A.