MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC DURAKNOT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SW100

Device Problems Break (1069); Sticking (1597)

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

Event Date 11/13/2017

Event Type  malfunction  

Event Description

Surgical assist broke during surgery, and surgeon stated he was having trouble with the device "sticking" before it broke.

• Brand Name: DURAKNOT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 7036808
• MDR Text Key: 92216062
• Report Number: 7036808
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: SW100
• Device Catalogue Number: SW100
• Device Lot Number: P9377Y
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2017
• 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