MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 ART STRA SEALER 45CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLG2S45A
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u9518w.The product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslg2s45a device was received with the top of the i-blade fractured and slightly lifted.The device was connected to the generator and it was recognized.Because the i blade was damaged not all functional testing could be performed with the generator.Therefore, we were unable to investigate further the alert screen issues reported.The jaws were found attached to the instrument.In addition, no pieces were found missing under microscope inspection.The condition of the blade prevented the functionality of the jaw.The jaw was unable to cycle open and close.It should be noted that product failure is multifactorial.A probable cause of the damage to the i blade could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a gastrectomy procedure, the doctor was using enseal nslg2s45a to mobilize the stomach and the was throwing an error code in middle of procedure tried to unplug to reset and didn¿t work.There was a five-minute delay.The device was replaced, and the procedure was completed with no patient consequences.

• Brand Name: ENSEAL G2 ART STRA SEALER 45CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11278323
• Report Number: 3005075853-2021-00661
• Device Sequence Number: 17071684
• Product Code: GEI
• UDI-Device Identifier: 10705036014560
• UDI-Public: 10705036014560
• Combination Product (Y/N): N
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: NSLG2S45A
• Device Catalogue Number: NSLG2S45A
• Device Lot Number: U9518W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR