MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC ENDOPATH; STAPLE, IMPLANTABLE

Model Number	ATB35
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Device misfired.

• Brand Name: ENDOPATH
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 7684977
• Report Number: 7684977
• Device Sequence Number: 634477
• Product Code: GDW
• UDI-Device Identifier: 10705036012313
• UDI-Public: (01)10705036012313
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/04/2017
• Report Date (Section F): 07/06/2018

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: ATB35
• Device Catalogue Number: ATB35
• Device Lot Number: N90U9V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/06/2018