MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 25CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLG2C25
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u93j9p.Investigation summary: the device was received with no apparent damage.Upon visual inspection under magnification it was noticed that the upper jaw was slightly damaged at the retention pin interphase.Resulting in the jaw been loose and difficulty in opening and closing of the jaws.However the damage was not significant enough to prevent the device from cycling.The devices was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All three tones were heard during functional testing (tone 1 is heard when the energy activation button is pressed; tone 2 is heard when tissue impedance threshold is reached; and tone 3 is heard when the cycle is complete).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 an open pancreaticoduodenectomy, in the middle of the operation, the jaws became loose.The jaws could not be opened or closed.The device had clamped thick tissue several times.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: ENSEAL G2 CURVED JAW 25CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10374996
• Report Number: 3005075853-2020-03986
• Device Sequence Number: 2888766
• Product Code: GEI
• UDI-Device Identifier: 10705036014133
• UDI-Public: 10705036014133
• 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
• Report Date (Section B): 07/16/2020

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: 08/05/2020
• Device Model Number: NSLG2C25
• Device Catalogue Number: NSLG2C25
• Device Lot Number: U93J9P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/06/2020
• Patient Sequence Number: 1