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

Model Number	IPN925056
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use on a patient "the product does not do its job when the clips do not come off on the first try".Additional information received states that "during the event, the patient was in unnecessary pain.The skin is damaged and prolonged the removal of the staples, causing the patient anxiety and fear".The current patient status is reported as "good".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during use on a patient "the product does not do its job when the clips do not come off on the first try".Additional information received states that "during the event, the patient was in unnecessary pain.The skin is damaged and prolonged the removal of the staples, causing the patient anxiety and fear".The current patient status is reported as "good".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "failure to function-not removing staples" 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 reveal 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19021687
• Report Number: 3003898360-2024-00316
• Device Sequence Number: 7980863
• Product Code: QQS
• UDI-Device Identifier: 14026704631763
• UDI-Public: 14026704631763
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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 Model Number: IPN925056
• Device Catalogue Number: 525980
• Device Lot Number: 73K2200278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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