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	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Stapler fired but staple line of anatomy not intact, no staples on line of anatomy like there should be, staple line had to be sewn closed.

• Brand Name: PROXIMATE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 14591865
• Report Number: 14591865
• Device Sequence Number: 5426660
• Product Code: GDW
• UDI-Device Identifier: 10705036013389
• UDI-Public: (01)10705036013389(17)260831(10)470A89
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/17/2022
• Report Date (Section F): 05/17/2022

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: 470A89
• 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: 06/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2022
• 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: Unknown
• Date Report Sent to FDA: 05/17/2022