MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. DURAKNOT; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	SW100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
After multiple duraknots were fired, the equipment began malfunctioning.The item was removed from the sterile field, and a replacement was opened to the sterile field, which worked with no issues.It is unknown whether the replacement system was from the same lot or a different lot.The or team has been asked to capture this information for future events.

• Brand Name: DURAKNOT
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 3801 university blvd se; albuquerque NM 87106
• MDR Report Key: 7291661
• Report Number: 7291661
• Device Sequence Number: 19051788
• Product Code: GCJ
• UDI-Device Identifier: 10705036002888
• UDI-Public: (01)10705036002888(17)220930(10)P93W0U
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2018
• Report Date (Section F): 02/13/2018

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: Physician
• Device Expiration Date: 09/30/2022
• Device Model Number: SW100
• Device Catalogue Number: SW100
• Device Lot Number: P93W0U
• Other Device ID Number: A93358P02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO
• Patient Age: 52 YR
• Patient Weight: 85
• Date Report Sent to FDA: 02/13/2018