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

Model Number	NSLG2C45A
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 #u93059.Investigation summary: the device was returned with the bottom portion of the i blade out of the lower jaw channel; the lower jaw channel was damaged.The device was connected to the generator and it was recognized.Because of the condition of the device not all functional testing could be performed with the generator.The jaw was unable to cycle open and close.As part of our quality process.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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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 urological surgery, the jaws did not open and close well before use.The device was not used for the patient.Gen11 was used.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 ART CURV 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: 10586307
• Report Number: 3005075853-2020-04916
• Device Sequence Number: 13757580
• Product Code: GEI
• UDI-Device Identifier: 10705036014553
• UDI-Public: 10705036014553
• 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): 09/01/2020

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: NSLG2C45A
• Device Catalogue Number: NSLG2C45A
• Device Lot Number: U9364D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/25/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.