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

Catalog Number	528235
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the stapler casing is cracked." this was observed prior to use.No patient involvement.
Additional Manufacturer Narrative
(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 and open edges in the top left corner of the packaging.The sterile barrier of the returned sample is compromised due to the packaging damage.A capa was opened to further investigate this issue.Root cause is identified in the capa.Dimensional, functional, and additional testing was not required as part of this complaint investigation.Per dhr the product visistat 35w 6/box lot # 73g2200732 was manufactured on 07/25/2022 a total of 27,000 pieces.Lot was released on 08/10/2022.Dhr investigation did not show issues related to complaint.The sterile barrier of the returned sample is compromised due to the packaging damage.A capa has been previously opened to further investigate this issue.The reported complaint of broken package - sterility compromised 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 iden tified 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17651940
• Report Number: 3003898360-2023-01274
• Device Sequence Number: 6457365
• Product Code: QQS
• UDI-Device Identifier: 14026704631787
• UDI-Public: 14026704631787
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 08/24/2023

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: 73G2200732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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