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

Model Number	IPN008820
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review for the product visistat 35w non-sterile lot #73h2000208 investigation did not show issues related to the complaint.
Event or Problem Description
Certified surgical technician was attempting to staple the sterile drapes together and the stapler that came in the ortho/trauma pack fell apart after the first use.The staple cartridge completely fell out, as did all the staples on top of the patient.Surgical site was the left elbow, and not near the malfunction.No known injury to patient, but loose staples were collected as much as possible to prevent any possible injury.
Additional Manufacturer Narrative
Qn#(b)(4).Per dhr the product visistat 35w non-sterile lot # 73h2000208 was manufactured on 08/11/2020 a total of (b)(6) pieces.Lot was released on 08/20/2020.Dhr investigation did not show issues related to complaint.The customer returned one unit 528236 visistat 35w non-sterile for investigation.The returned stapler was visually examined with and without magnification.Visual examination of the returned sample revealed that the bottom and rail were detached from the cover block.The bottom and rail were not returned and there were no staples remaining.It appears that the bottom was not properly welded onto the cover block, which allowed the rail, pusher and staples to fall out of the stapler.A nonconformance has been opened by the manufacturing site as a result of this issue.It appears that the bottom was not properly welded to the cover block, which allowed the rail and the staples to fall out from the stapler.A nonconformance has been opened by the manufacturing site as a result of this issue.The reported complaint of "broken - staple feed assembly" was confirmed based on the returned sample.The stapler was returned with the bottom and rail detached from the cover block.The bottom and rail were not returned and there were no staples remaining in the device.It appears that the bottom was not properly welded to the cover block, which allowed the rail, pusher and staples to fall out from the stapler.A nonconformance has been opened by the manufacturing site as a result of this issue.
Event or Problem Description
Certified surgical technician was attempting to staple the sterile drapes together and the stapler that came in the ortho/trauma pack fell apart after the first use.The staple cartridge completely fell out, as did all the staples on top of the patient.Surgical site was the left elbow, and not near the malfunction.No known injury to patient, but loose staples were collected as much as possible to prevent any possible injury.

• Brand Name: VISISTAT 35W NON-STERILE
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11992816
• Report Number: 3003898360-2021-00560
• Device Sequence Number: 14253450
• Product Code: GDT
• UDI-Device Identifier: 34026704630302
• UDI-Public: 34026704630302
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 73H2000208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.