MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W NON-STERILE; STAPLE, REMOVABLE (SKIN)

Model Number	IPN914814
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Use of the stapler to fix the skin at the end of the operation, but the staples do not hold well to the skin and come off at the slightest contact with the scar.Clinical consequences: unknown at this time.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
Use of the stapler to fix the skin at the end of the operation, but the staples do not hold well to the skin and come off at the slightest contact with the scar.Clinical consequences: unknown at this time.
Additional Manufacturer Narrative
Qn#(b)(4).Per dhr the product visistat 35w non-sterile lot # 73f2100457 was manufactured on (b)(6) 2021 a total of (b)(4) pieces.Lot was released on (b)(6) 2021.Dhr investigation did not show issues related to complaint.P/n 528236 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 13 staplers were taken from the current production from p/n 528235 visistat 35w 6/box lot# 73d2200410 the staplers were functionally inspected and issue reported "failure to function - staple re-opens" was not observed in the current manufacturing process, the staples were loaded and released correctly.Revision of fmea-08-028 rev 05 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.

• Brand Name: VISISTAT 35W NON-STERILE
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14187961
• Report Number: 3003898360-2022-00157
• Device Sequence Number: 14573080
• Product Code: QQS
• UDI-Device Identifier: 34026704631798
• UDI-Public: 34026704631798
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: IPN914814
• Device Catalogue Number: 528236
• Device Lot Number: 73F2100457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown