MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENSEAL LAPAROSCOPIC TISSUE SEALER G2 5MM/35CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number NSLG2C35

Device Problems Material Protrusion/Extrusion (2979); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

Device gave error, was removed from patient and jaws were noted to have a wire protruding from one side.Item was removed from field and replaced.

• Brand Name: ENSEAL LAPAROSCOPIC TISSUE SEALER G2 5MM/35CM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 14631015
• MDR Text Key: 293531716
• Report Number: 14631015
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLG2C35
• Device Catalogue Number: NSLG2C35
• Device Lot Number: X94F44
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Sex: Female
• Patient Weight: 96 KG