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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: t94p8d.The device was received the upper jaw damaged at the proximal side.In addition, there were no damaged observed at the ptc as reported.The device was connected to the generator and it was recognized.Because the jaw was damaged not all functional testing could be performed with the generator.The condition of the jaws prevented the functionality of the jaw.The device was unable to cycle open and close.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.
Event or Problem Description
It was reported that during a sigmoid colectomy, a piece of the inner lining that contains an i-beam protruded away from the distal top portion of the jaw but still secured on the device.No part of the device separated from the device and nothing fell into the patient.The surgeon asked for a new device and continued to complete the case.No patient complications.

• 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: 10942033
• Report Number: 3005075853-2020-06374
• Device Sequence Number: 11560636
• 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): 11/12/2020

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: 09/30/2024
• Device Model Number: NSLG2S45A
• Device Catalogue Number: NSLG2S45A
• Device Lot Number: T94U9U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1