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

Catalog Number	528135
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staple will not come out from the stapler.A new stapler was used to complete the procedure.No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 20 staplers were taken from the current production from part number 528135 visistat 35r 6/box lot number 73c2400176 the staplers were functionally inspected (fired) and issue reported "misfire/jam - staples not releasing" was not observed in the current manufacturing process, the staples were loaded and released correctly.Dhr investigation did not show issues related to complaint.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The reported complaint of misfire/jam - staples not releasing was confirmed based upon the sample received.The customer returned one unit of 528135 visistat 35r 6/box for investigation.Visual examination of the returned sample revealed that the first staple appeared misaligned.The stapler was returned with 23 staples remaining in the cover block, indicating that at least 12 staples were fired by the customer.The trigger was not returned engaged.No clear evidence of use in the form of biological material was observed on the device.Upon functional inspection, an attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon engagement of the trigger, the first staple fired properly.To simulate insertion into the skin, the remaining staples were fired into a simulated skin pad.It appeared that the staple misalignment prevented the next two staples from firing properly.Die casting anomalies were discovered on the forming tool.No flash was observed within the cover block.No other defects or anomalies were observed.The source of the staple misalignment could not be conclusively determined.Further investigation has been initiated under teleflex's quality system by the manufacturing site to evaluate this issue.Other remarks: n/a.Corrected data: correction to section d.4.Udi was updated from (b)(4) to include the full udi.
Event or Problem Description
It was reported that the staple will not come out from the stapler.A new stapler was used to complete the procedure.No patient harm or injury.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19059294
• Report Number: 3003898360-2024-00361
• Device Sequence Number: 20502458
• 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,Followup
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 528135
• Device Lot Number: 73F2300576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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