MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W NON-STERILE; STAPLE, REMOVABLE (SKIN)

Model Number	IPN008820
Medical Device Problem Codes	Failure to Form Staple (2579); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review of the product visistat 35w non-sterile lot #73k2000440 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The staples of the skin stapler closed incorrectly so that they do not fit properly on the patient's skin.There was no medical complication and no treatment required.
Additional Manufacturer Narrative
(b)(4).The device history review of the product visistat 35w non-sterile lot #73k2000440 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.During visual inspection was observed; staples were received in correct position.Trigger was observed pre-activated.Functional inspection performed as follows.Device was activated (fired) the staplers were properly formed and released, none defects were observed during develop of this testing.A verification of failure mode reported in the current manufacturing process was conducted as follows: 13 staplers were taken from the current production from p/n 528236 visistat 35w non-sterile lot# 73j2100436 the staplers were functionally inspected (fired) and issue reported "misfire/jam-staples not forming/closing" was not observed in the current manufacturing process, the staples were loaded and released correctly.Revision of fmea-08-028 rev 05 was performed and the failure mode is already including it, no update is required.A corrective action is not required at this time as the reported complaint could not be confirmed for the sample that was returned.One (1) stapler from catalog number 528236 visistat 35w was received, used, without original package, only complaint documentation.During visual inspection was observed.Staples were received in correct position.Trigger was observed pre-activated, during functional testing the stapler was formed and released properly the staplers.A total of 10 staplers were fired and no defects were detected during this testing; therefore, at this time is not possible confirmed the defect reported "jamming".
Event or Problem Description
The staples of the skin stapler closed incorrectly so that they do not fit properly on the patient's skin.There was no medical complication and no treatment required.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12568069
• Report Number: 3003898360-2021-00917
• Device Sequence Number: 3913189
• Product Code: GDT
• UDI-Device Identifier: 34026704630302
• UDI-Public: 34026704630302
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/16/2021

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: IPN008820
• Device Catalogue Number: 528236
• Device Lot Number: 73K2000440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown