MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W 6/BOX; STAPLE, REMOVABLE (SKIN)

Model Number	IPN008819
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that (b)(6) 2021, the staple was found jamming and could not be fired prior to the patient.
Event or Problem Description
It was reported that on (b)(6) 2021, the staple was found jamming and could not be fired prior to the patient.
Additional Manufacturer Narrative
(b)(4).Per dhr the product visistat 35w 6/box lot#: 73c1900104 was manufactured on 03/05/2019 a total of (b)(4) pieces.Lot was released on 03/13/2019.Dhr investigation did not show issues related to complaint.The customer returned one unit 528235 visistat 35w 6/box for investigation.The returned stapler was visually examined with and with out magnification.Visual examination of the returned stapler revealed that the sample had its trigger partially engaged.The staples appeared to be properly aligned.The stapler was received with 37 staples left in the device.Functional inspection was performed by attempting to fire staples from the device.Using hand pressure, the trigger was engaged in order to complete the trigger cycle.Upon full engagement of the trigger, the first staple was able to properly form and release from the device.These actions were repeated for the next 4 staples with the same result.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.All 32 remaining staples were able to properly fire and close into the skin pad.All staples were fired from the device with no difficulty.No defects or anomalies were observed.The ifu for this product, l02644, was reviewed as a part of this complaint investigation.The ifu states "to obtain optimum staple c losure, the trigger must be squeezed all the way in." a corrective action is not required at this time as there were no functional issues found with the returned device.The stapler was able to properly fire all remaining staples.The reported complaint of "misfire/jamming - staples not firing" could not be confirmed based upon the sample received.The returned stapler was able to form and release all remaining staples in the cover block.No defects or anomalies were observed with the sample.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned stapler.

• Brand Name: VISISTAT 35W 6/BOX
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11342243
• Report Number: 3003898360-2021-00189
• Device Sequence Number: 12011218
• Product Code: GDT
• UDI-Device Identifier: 04026704600762
• UDI-Public: 04026704600762
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/21/2021

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: IPN008819
• Device Catalogue Number: 528235
• Device Lot Number: 73C1900104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/09/2021
• 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.