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

Model Number IPN028492

Device Problem Failure to Form Staple (2579)

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

Event Date 06/15/2021

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 did not smoothly come out from the stapler and also some staples were not properly formed.Therefore, a new unit was used instead.

Event Description

The staples did not smoothly come out from the stapler and also some staples were not properly formed.Therefore, a new unit was used instead.

Manufacturer Narrative

(b)(4).Per dhr the product visistat 35r 6/box lot # 73k1900468 was manufactured on 10/18/2019 a total of (b)(4) pieces.Lot was released on 11/01/2019.Dhr investigation did not show issues related to complaint.A verification of failure mode reported in the current manufacturing process was conducted as follows: 13 staplers were taken from the current production from p/n 528135 visistat 35r 6/box lot# 73f2100163 the staplers were functionally inspected (fired) and issue reported "misfire/jam-staples not forming/closing" 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.

Manufacturer Narrative

Qn#: (b)(4).The customer returned one unit 528135 visistat 35r 6/box for investigation.The sample also applies to tc (b)(4).The returned s tapler was visually examined with and without magnification.Visual examination of the returned stapler revealed that the trigger was partially engaged.The staples appeared slightly misaligned on one side of the cover block.The stapler was received with 18 staples left in the device indicating that at least 17 staples were fired by the end user.Functional inspection was performed by attempting to complete the trigger cycle and fire staples from the device.Using hand pressure, the trigger was engaged.Upon full engagement of the trigger, the trigger cycle was able to be completed and the first staple was able to properly form and release from the device.These actions were repeated for the next 4 staples with the same result.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.All 13 remaining staples were able to properly fire and close into the skin pad.All staples were fired from the device with no difficulty.The device was disassembled and it was confirmed to have been assembled correctly.The ifu for this product, l02644, was reviewed as a part of this complaint investigation.The ifu states "to obtain optimum staple c losure, the trigger must be squeezed all the way in." a corrective action is not required at this time as there were no functional issues found with the returned device.The stapler was able to properly fire all remaining staples.The reported complaint of "misfire/jam - staples not forming/closing" could not be confirmed based upon the sample received.The returned stapler was able to form and release all remaining staples in the cover block.Although the staples appeared slightly misaligned on one side of the cover block, no functional defects were observed with the sample.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned stapler.

Event Description

The staples did not smoothly come out from the stapler and also some staples were not properly formed.Therefore, a new unit was used instead.

• Brand Name: VISISTAT 35R 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12017270
• MDR Text Key: 256738157
• Report Number: 3003898360-2021-00574
• 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,Followup
• Report Date: 06/15/2021

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: IPN028492
• Device Catalogue Number: 528135
• Device Lot Number: 73K1900468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 06/17/2021; 08/03/2021
• Supplement Dates FDA Received: 07/12/2021; 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.