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 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

When the user fired a staple the staple came out from the stapler only a little not enough to suture the skin.Therefore, a new unit was used instead.

Manufacturer Narrative

Qn#(b)(4).Although a lot number was not originally reported, a potential lot number was obtained through the sales history.The potential lot is 73b2000297.Per dhr the product visistat 35r 6/box lot # 73b2000297 was manufactured on 02/12/2020 a total of (b)(4) pieces.Lot was released on 02/24/2020.Dhr investigation did not show issues related to complaint.The customer returned one unit 528135 visistat 35r 6/box for investigation.The returned stapler was visually examined with and with out magnification.Visual examination of the returned sample revealed that the staples appeared to be properly aligned.The stapler was received with 29 staples remaining indicating that at least 6 staples were fired by the end user.In order to functionally inspect the sample, an attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.The first two staples properly formed and released, however the third staple did not release.The next 4 staples properly formed and fired from the device.The device was disassembled for further inspection.Upon disassembly, no defects or anomalies were observed.The device was reassembled and an attempt was made to fire the remaining 22 staples into a skin pad in order to simulate skin insertion.There were 7 out of the 22 staples that were partially formed when released into the skin pad.The manufacturing site was consulted for this complaint.It could not be determined what exactly caused some of the staples to partially form when fired.Therefore, although the complaint is confirmed, the root cause is undetermined.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 the root cause of this complaint could not be determined.Although the staples were only able to partially form, no defects were observed with the staples or any of the stapler components.All staplers are 100% inspected at manufacturing for firing at the time of assembly so it is unlikely that this issue was present at the time of manufacturing assembly.The reported complaint of "misfire/jam - staples not forming/closing" was confirmed based upon the sample received.Upon functional inspection, some of the staples were only able to partially form when fired from the device.The sample was disassembled and no defects were observed with any components.All staplers are 100% inspected at manufacturing for firing at the time of assembly.A device history record review was performed with no evidence to suggest a manufacturing related cause.Therefore, the root cause for this complaint cannot be determined.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

When the user fired a staple the staple came out from the stapler only a little not enough to suture the skin.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: 12238585
• MDR Text Key: 263833559
• Report Number: 3003898360-2021-00665
• 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
• Report Date: 07/20/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1