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

Catalog Number	525980
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi#:(b)(4).
Event or Problem Description
It was reported that " the user removed the staples smoothly at the beginning of the surgery, however, he/she felt it difficult to remove after a while.Therefore, the remover was replaced with a new one to complete the procedure.No injury to the patient was reported".
Event or Problem Description
It was reported that the user removed the staples smoothly at the beginning of the surgery, however, he/she felt it difficult to remove after a while.Therefore, the remover was replaced with a new one to complete the procedure.No injury to the patient was reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of 525980 weckstat staple extractor 12/box.The sample was visually examined with and without magnification.Visual examination of the returned sample revealed no clear evidence of use in the form of biological material.No defects or anomalies were observed on the returned sample.Functional inspection was performed by attempting to remove staples that were fired onto a simulated skin pad.All staples (25 wide) were successfully removed from the simulated skin pad with no difficulty.No functional issues were found with the returned sample.A device history record review was performed and no relevant findings were identified.The ifu for this product states, "place lower jaws of staple remover under the top span of the staple.Squeeze handle to retract staple legs.Lift the staple away from the wound to release and dispose of staple." the reported complaint could not be confirmed based upon the sample received.The returned staple extractor was able to successfully remove all tested staples from the simulated skin pad with no difficulty.Visual and functional inspection did not confirm any looseness in the jaws.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned staple extractor.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19720329
• Report Number: 3003898360-2024-00819
• Device Sequence Number: 8290281
• Product Code: QQS
• UDI-Device Identifier: 14026704631763
• UDI-Public: (01)14026704631763(11)231115(17)281114(10)73L2300526(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/13/2024

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
• Device Catalogue Number: 525980
• Device Lot Number: 73L2300526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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