MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC PROXIMATE; STAPLE, IMPLANTABLE

Model Number	TVC55
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Vascular gia stapling device was then used to come across the fistula from the lateral side, but it clearly fully misfired--when had could cut across only approximately half of the tract with the stapler became locked up.As such, the stapler was disengaged.We then used a completely new vascular gia stapler device with a new load of staples, and this time tried to use that stapler coming from the medial side.We waited at least 30 seconds prior to firing the stapler as we had with the first stapler, and again when trying to complete the cut with the stapler, the mechanisms simply would not advance after the stapler had cut across approximately half the width of the fistula tract tissues on the medial side.As such, that stapler was removed.

• Brand Name: PROXIMATE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 18535465
• Report Number: 18535465
• Device Sequence Number: 7587512
• Product Code: GDW
• UDI-Device Identifier: 10705036013389
• UDI-Public: (01)10705036013389(17)231231(10)T40254
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2023
• Report Date (Section F): 09/11/2023

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: TVC55
• Device Catalogue Number: TVC55
• Device Lot Number: T40254
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 16 KG
• Date Report Sent to FDA: 09/11/2023