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
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of misfire/jamming - staples not firing was confirmed based upon the sample received.Visual examination revealed that the first three staples appeared to be misaligned.Upon functional inspection, the misalignment of the first three staples prevented the remaining staples from firing correctly.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.The sample was disassembled.Die casting were observed anomalies on the forming tool.No flash was discovered in the cover block.An investigation within teleflex was opened by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a corrected data: n/a.
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.

• 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: 18916380
• Report Number: 3003898360-2024-00306
• Device Sequence Number: 20556152
• 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): 03/11/2024

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?: No
• 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: 03/11/2024
• 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