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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "staples appear to be bent and do not close the skin staple seam well".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was available 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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "staples appear to be bent and do not close the skin staple seam well".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was available 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.Corrected data: corrected section e.Initial reporter address from unknown to (b)(6).
Event or Problem Description
It was reported that "staples appear to be bent and do not close the skin staple seam well".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17654851
• Report Number: 3003898360-2023-01275
• Device Sequence Number: 12607623
• Product Code: QQS
• UDI-Device Identifier: 04026704600779
• UDI-Public: 04026704600779
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2023

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: 73K2200081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 08/31/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/12/2023; 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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