MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK VISISTAT SKIN STAPLER 35W; STAPLE, REMOVABLE (SKIN)

Catalog Number	528235
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	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the package was found broken during inspection.Involved 516 pcs.All of the defects found during the same exact inspection at the same time.The outer box was not damaged." no patient involvement.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned 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 "the package was found broken during inspection.Involved 516 pcs.All of the defects found during the same exact inspection at the same time.The outer box was not damaged." no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The reported complaint was able to be confirmed by the photo.The customer also 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 reported complaint was confirmed based upon the sample received.Visual examination of the returned sample revealed that the packaging is damaged to the point of a compromised sterile barrier.A capa has been previously opened to further investigate this issue.Root cause is identified in the capa.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: WECK VISISTAT SKIN STAPLER 35W
• 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: 17669880
• Report Number: 3003898360-2023-01315
• Device Sequence Number: 7105506
• Product Code: QQS
• UDI-Device Identifier: 14026704631787
• UDI-Public: 14026704631787
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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 Catalogue Number: 528235
• Device Lot Number: 73H2200271
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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