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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u9335v.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Additional information was requested, and the following was obtained: the surgeon cut the tissue along the jaw by an electrical cautery.There was no bleeding and tissue damage because the tissue was sealed by the device.The patient is stable.
Event or Problem Description
It was reported that during a robot-assisted procedure on the malignant tumor of the prostate gland, the jaws became not to open during use.The device was released by cutting the tissue around the device by the electric knife.The blade tip was not broken off and no pieces fell into the patient.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: (b)(6) 2020.D4: batch # t9598f.The device was received the upper jaw bent.The device was connected to the gen 11 and it was recognized.However, due to condition of the device no functional testing could be performer.The condition of the jaw prevented the functionality of the device.The instrument was unable to fully cycle open and close.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.

• 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
• MDR Report Key: 10851782
• Report Number: 3005075853-2020-06057
• Device Sequence Number: 19635936
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: 12/31/2024
• Device Model Number: NSLG2S45A
• Device Catalogue Number: NSLG2S45A
• Device Lot Number: U9335V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 11/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR; GENERATOR