MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ECHELON FLEX ENDOPATH; STAPLE, IMPLANTABLE

Model Number	PLE45A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During laparoscopic placement of peritoneal dialysis catheter, linear cutter would not engage when the surgeon attempted to use the device.New device was used without any issues.No patient harm.Device to be returned to manufacturer for evaluation.

• Brand Name: ECHELON FLEX ENDOPATH
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; ml 120a; cincinnati OH 45242
• MDR Report Key: 7103835
• Report Number: 7103835
• Device Sequence Number: 1749745
• Product Code: GDW
• UDI-Device Identifier: 10705036014379
• UDI-Public: (01)10705036014379
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/06/2017
• Report Date (Section F): 12/06/2017

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: Physician
• Device Model Number: PLE45A
• Device Catalogue Number: PLE45A
• Device Lot Number: P91L29
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 12/06/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2017
• 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: 12/06/2017