MAUDE Adverse Event Report: TELEFLEX MEDICAL WECKSTAT STAPLE EXTRACTOR 12/BOX; STAPLE, REMOVABLE (SKIN)

Model Number	IPN917215
Medical Device Problem Codes	Break (1069); Defective Device (2588); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.
Event or Problem Description
It was reported that "when the nurse was using the device to remove a staple, the device snapped the staple in half and the staple flew upwards and hit the nurse on the cheek.The remaining half of the staple was removed from the patient with nil harm caused".No further information is available.

• Brand Name: WECKSTAT STAPLE EXTRACTOR 12/BOX
• 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: 22719038
• Report Number: 3003898360-2025-00614
• Device Sequence Number: 9627868
• Product Code: QQS
• UDI-Device Identifier: 14026704631763
• UDI-Public: (01)14026704631763(11)240920(17)290919(10)73J2400598(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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 Model Number: IPN917215
• Device Catalogue Number: 525980
• Device Lot Number: 73J2400598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2024
• 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