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

Model Number	NSLG2S45
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u9563r.Investigation summary: 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 nslg2s45 device was received with no apparent damage.The device was tested with a generator, the hand activation was not functional.However the device worked properly with footswitch.There were no replace instrument alert screen as reported.The instrument was disassembled to inspect the internal components and it was noted that the hand activation switch button was damaged.This caused the hand activation failure.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what caused this issue.Please reference the instruction for use for more information.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported that during a laparoscopic sleeve gastrectomy, the gen11 displayed a warning message to change the instrument.The instrument didn't activate anymore.They had to take another same like device to complete the procedure.No patient consequence.

• Brand Name: ENSEAL G2 STRAIGHT JAW 45CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12233681
• Report Number: 3005075853-2021-04184
• Device Sequence Number: 12113350
• Product Code: GEI
• UDI-Device Identifier: 10705036014195
• UDI-Public: 10705036014195
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 08/31/2025
• Device Model Number: NSLG2S45
• Device Catalogue Number: NSLG2S45
• Device Lot Number: U95D0E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR