MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W 6/BOX; STAPLE, REMOVABLE (SKIN)

Model Number	IPN008819
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during product inspection a package was found "broken".Upon further review, the damage occurred to all 106 pieces.All pieces are from the same lot number.No patient involvement.
Additional Manufacturer Narrative
Qn#(b)(4).Per dhr the product visistat 35w 6/box lot # 73f2200179 was manufactured on (b)(6) 2022 a total of 27,000 pieces.Lot was released on (b)(6) 2022.Dhr investigation did not show issues related to complaint.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit of 528235 visistat 35w 6/box for investigation.The individual returned unit was an unopened sample in its original packaging.The packaging of the returned unit was observed to be damaged, with cracking near the tip of the device where the staples are ejected.The sterile barrier of the returned sample is compromised due to the packaging damage.A device history record review was performed and no relevant findings were identified.The complaint has been confirmed.A capa was opened to further investigation this issue.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that during product inspection a package was found "broken".Upon further review, the damage occurred to all 106 pieces.All pieces are from the same lot number.No patient involvement.

• Brand Name: VISISTAT 35W 6/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: 16709423
• Report Number: 3003898360-2023-00587
• Device Sequence Number: 17624850
• Product Code: QQS
• UDI-Device Identifier: 04026704600762
• UDI-Public: 04026704600762
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: IPN008819
• Device Catalogue Number: 528235
• Device Lot Number: 73F2200179
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown