MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENSEAL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number NSLG2S35

Device Problems Difficult to Open or Close (2921); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2020

Event Type  malfunction  

Event Description

During a laparoscopic salpino oophorectomy & lysis of adhesions procedure, the ethicon ligasure device failed.Staff reported the jaws failed to open and close.

• Brand Name: ENSEAL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 11177009
• MDR Text Key: 227022514
• Report Number: 11177009
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2021

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
• Device Operator: No Information
• Device Model Number: NSLG2S35
• Device Catalogue Number: NSLG2S35
• Device Lot Number: U93X30
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1