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

Model Number	IPN008819
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Staples did not come out from the device therefore, a new unit was used instead.
Event or Problem Description
Staples did not come out from the device therefore, a new unit was used instead.
Additional Manufacturer Narrative
Qn#(b)(4).Although a lot number was not originally reported, a potential lot number was obtained through the sales history.The lot is 73m1900182.Per dhr the product visistat 35w 6/box lot # 73m1900182 was manufactured on 12/10/2019 a total of (b)(4) pieces.Lot was released on 12/19/2019.Dhr investigation did not show issues related to complaint.The customer returned one unit 528235 visistat 35w 6/box for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the staples appeared misaligned.The trigger was returned partially engaged.The sample appears used as there was biological material observed on the device.The stapler was returned with 37 staples left in the cover block.An attempt to fire staples was made by engaging the trigger of the stapler using hand pressure.Upon engagement of the trigger, the trigger cycle was completed but no staple fired.Multiple attempts were made but no staples fired.It appeared that the misalignment of the staples was preventing the staples from moving down the track and into the forming tool.An attempt was made to manually realign the staples , but the staples were unable to be realigned.The stapler was disassembled , and it was confirmed to have been assembled correctly.No other defects or anomalies were observed with the device.It could not be determined what exactly caused the staples to misalign.A nonconformance has been opened by the manufacturing site to further investigate visistat jamming issues.It could not be determined what caused the staples to misalign.A nonconformance has been opened by the manufacturing site to further investigate this visistat jamming issue.The reported complaint of "misfire/jamming - staples not firing" was confirmed based upon the sample received.Visual examination revealed that the staples were misaligned.Upon functional inspection, the misalignment of the staples prevented any staples from firing.The sample was disassembled , and no other defects or anomalies were observed.It could not be determined what caused the staples to misalign.A nonconformance has been opened by the manufacturing site to further investigate visistat jamming issues.

• Brand Name: VISISTAT 35W 6/BOX
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12127226
• Report Number: 3003898360-2021-00622
• Device Sequence Number: 11660828
• Product Code: GDT
• UDI-Device Identifier: 04026704600762
• UDI-Public: 04026704600762
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/24/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1