MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK VISISTAT SKIN STAPLER 35R; STAPLE, REMOVABLE (SKIN)

Catalog Number	528135
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "hospital reported that our skin stapler got issues cannot work to close the wound".At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of 528135 visistat 35r 6/box for investigation.Visual examination revealed that the staples were severely misaligned.The trigger was not returned engaged and no clear evidence of use in the form of biological material was present on the device.A functional inspection was performed on the sample by attempting to fire staples from the returned stapler.Upon engagement of the trigger, two staples jammed in the front of the device and did not form or release.The two unformed staples were manually removed from the device.Another attempt was made and no staples fired.The stapler was disassembled, and it was observed that the saddle spring was disconnected from the red pusher, which allowed for the staples to move freely within the cover block.No flash was observed within the cover block.In addition, die casting anomalies were discovered on the forming tool.A non-conformance was opened by the manufacturing site to further investigate this issue.Per dhr the product visistat 35r 6/box lot # 73j2200727 was manufactured on 09/27/2022 a total of 15,003 pieces.Lot was released on 10/12/2022.Dhr investigation did not show issues related to complaint.The ifu for this product 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." the reported complaint of misfire/jamming-misaligned staples was confirmed based upon the sample received.Upon engagement of the trigger, the first staple misfired.On the next attempt, two staples jammed in the front of the device and did not form or release.The two unformed staples were manually removed from the device.Another attempt was made and no staples fired.The sample was disassembled.It was observed that the saddle spring was disconnected form the red pusher.Die casting were observed anomalies on the forming tool.No flash was discovered in the cover block.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: WECK VISISTAT SKIN STAPLER 35R
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19008396
• Report Number: 3003898360-2024-00303
• Device Sequence Number: 18251279
• Product Code: QQS
• UDI-Device Identifier: 14026704631770
• UDI-Public: 14026704631770
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 528135
• Device Lot Number: 73J2200727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown