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

Model Number SW100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2018

Event Type  malfunction  

Event 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
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 3801 university blvd se; albuquerque NM 87106
• MDR Report Key: 7291661
• MDR Text Key: 100783633
• Report Number: 7291661
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036002888
• UDI-Public: (01)10705036002888(17)220930(10)P93W0U
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 02/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 52 YR
• Patient Weight: 85