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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related eve.
Event or Problem Description
We have received complaints after changing skin stapler from coviden to teleflex.The clamps do not adhere in the subcutaneous layer.It does not lock as it should.Have happened to many times and the customer want financial replacement.
Additional Manufacturer Narrative
Qn#(b)(4).Per dhr the product visistat 35w non-sterile lot # 73j2000213 was manufactured on 09/08/2020 a total of (b)(4) pieces.Lot was released on 09/18/2020.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# 73d2100584.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 (b)(4) 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.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
We have received complaints after changing skin stapler from coviden to teleflex.The clamps do not adhere in the subcutaneous layer.It does not lock as it should.Have happened to many times and the customer want financial replacement.

• Brand Name: VISISTAT 35W NON-STERILE
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11731763
• Report Number: 3003898360-2021-00432
• Device Sequence Number: 14508224
• Product Code: GDT
• UDI-Device Identifier: 34026704630302
• UDI-Public: 34026704630302
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/14/2021

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: 73J2000213
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1