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

Catalog Number	528135
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2023
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 of the returned sample revealed that the staples appeared severely misaligned.Of these misaligned staples, four staples were observed to be pointed toward the proximal end of the stapler.The stapler was returned with 32 staples remaining in the cover block, indicating that at least 3 staples were fired by the customer.The trigger was returned partially engaged.No clear evidence of use in the form of biological material was present on the device.Dimensional inspection was not required as a part of this complaint investigation.Upon functional inspection, it appeared that the staple misalignment prevented the remaining staples from firing.The trigger cycle was completed, and no staples fired.Proper functional testing could not be performed due to the severe misalignment of the staples.The stapler was disassembled, and it was confirmed to have been assembled correctly.Die casting anomalies were discovered on the forming tool of the returned sample.No other defects or anomalies were observed.Per dhr the product visistat 35r 6/box lot # 73a2300516 was manufactured on 01/17/2023 a total of (b)(4) pieces.Lot was released on 02/01/2023.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 sample was returned with its staples severely misaligned.Of these staples, four staples were observed to be pointed toward the proximal end of the stapler.Proper functional testing could not be performed due to the severe misalignment of the staples.The root cause of the staple misalignment could not be conclusively determined.A nonconformance was initiated to further investigate this complaint issue.The complaint of misfire/jamming - misaligned staples was confirmed based upon the sample received.Visual examination revealed that the staples appeared to be severely misaligned.Of these staples, two staples were observed to be pointed toward the proximal end of the stapler.Upon functional inspection, the misalignment of the staples prevented the remaining staples from firing correctly.Proper functional testing could not be performed due to the severe misalignment of the staples.The root cause of the staple misalignment could not be conclusively determined.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: 18914854
• Report Number: 3003898360-2024-00298
• Device Sequence Number: 6893023
• 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: 73A2300516
• 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: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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