MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENSEAL ARTICULATING LAPAROSCOPIC TISSUE SEALER G2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number U93F6P

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

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Surgeon using enseal during laparoscopic assisted vaginal hysterectomy.While clamped on vessel and cauterizing, the enseal stopped working and would not unclamp.Unknown double sided blade like metal piece noted coming out of back of enseal.Another vessel sealer opened and used to seal vessel above enseal.Clamp used to hold metal piece while enseal opened.Metal piece put in bag.Bag pulled out through vagina when specimen was removed.

• Brand Name: ENSEAL ARTICULATING LAPAROSCOPIC TISSUE SEALER G2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 11560398
• MDR Text Key: 242027051
• Report Number: 11560398
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/16/2021

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: Health Professional
• Device Lot Number: U93F6P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1