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 12/09/2020

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

It was reported that staples will not close properly.Additional information: there was no patient injury or medical intervention.The lot number is unknown.

Event Description

It was reported that staples will not close properly.Additional information: there was no patient injury or medical intervention.The lot number is unknown.

Manufacturer Narrative

Qn#(b)(4).The original complaint did not provide a lot number, however a potential lot number was found through the sales history.The potential lot number is 73m1900061.Per dhr the product visistat 35w 6/box lot # 73m1900061 was manufactured on 12/03/2019 a total of (b)(4).Pieces.Lot was released on 12/13/2019.Dhr investigation did not show issues related to complaint.The customer returned one unit 528235 visistat 35w 6/box for investigation.The returned stapler was visually examined with and with out magnification.Visual examination of the returned sample revealed that the device appeared typical.The staples appeared to be properly aligned.The stapler was returned with 32 staples left in the cartridge indicating that at least 3 staples were fired by the end user.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon engagement of the trigger, no staple loaded.This was repeated 2 more times with the same result.The stapler was disassembled for further inspection.No defects or anomalies were observed.Upon reassembly, the trigger was engaged again and a staple partially formed and got stuck in the device.Once removed, another attempt was made and a staple properly formed and fired.This was done 4 more times with the same result.To simulate insertion into the skin, the remaining staples were fired into a skin pad.All 26 remaining staples were able to successfully form and release into the skin pad.However, on the last attempt the trigger got stuck and did not complete the full trigger cycle.The device was disassembled again and it was found that the pawl was spun out of position.The pawl being spun out of position could have been preventing the staples from consistently firing properly.It could not be determined how or when the pawl got out of position.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 it cannot be determined what caused the pawl to spin out of position.All staplers are 100% inspected at manufacturing for firing at the time of assembly so it is unlikely that the pawl was out of position when it left the manufacturing site.The reported complaint of "misfire/jamming - staples not forming/closing" was confirmed based upon the sample received.On the first few attempts, no staple loaded or fired from the device.Upon disassembly, no defects were found.Upon reassembly, the device fired a partially formed staple and then all remaining staples properly formed and fired.However, on the last attempt the trigger did not complete the trigger cycle and it was found that the pawl was spun out of position.It could not be determined how or when the pawl got out of position.All staplers are 100% inspected at manufacturing for firing at the time of assembly so it is unlikely that the pawl was out of position when it left the manufacturing site.Since it could not be determined exactly when or how the pawl got spun out of position, the root cause of this complaint issue is undetermined.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11004281
• MDR Text Key: 222028104
• Report Number: 3003898360-2020-01040
• Device Sequence Number: 1
• Product Code: GDT
• 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: 12/09/2020

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
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1