MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 35CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLG2C35
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a nephrectomy the doctor used the instrument and it was noticed that the tissue is very thick.The doctor took too much tissue, he is told that if it is possible to take less tissue since the jaw can break.The upset doctor does not comply with this indication and ends up breaking the jaw.The procedure was completed successfully.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/14/2023.D4 batch #: a9c120.Additional information was requested and the following was obtained: the device was received at our analysis site with a piece of the ceramic missing.Q.During the surgical procedure, did any piece of the device fall off? a.No parts missing q.Did any piece of the device fall into the patient? a.No part fell on the patient, it was probably lost in the manipulation of the laparoscopy technician.If so, how was it retrieved? investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the device was received with the jaw detached.In addition, the electrode, ceramic and active rod was noted separated from the lower jaw but still attached to the active.The jaw was returned.Upon visual inspection under magnification, it was noted that the ceramic was partially missing.The ceramic was damaged by the separation of the electrode from the lower jaw.No functional testing could be performed as the condition of the device returned.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.There is insufficient evidence related to what caused the damage to the device.A manufacturing record evaluation was performed for the finished device batch a9c120, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/13/2023.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the device was received with the jaw detached at the welding point and it was returned.In addition, the electrode, ceramic and active rod were noted separated from the lower jaw but still attached to the active.Upon visual inspection under magnification, it was noted that the ceramic was partially missing.The ceramic was damaged by the separation of the electrode from the lower jaw.No functional testing could be performed as the condition of the device returned.A manufacturing record evaluation was performed for the finished device lot and batch numbers, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.As described in the ifu: do not use excessive force on the closing handle to close the jaws; grasp only as much tissue as will fit between the jaws where the current will pass.Greater amounts of tissue require more closing handle force.Excessive force could damage the device.Please reference the instruction for use for more information: there is insufficient evidence related to what caused the damage to the electrode.H6 investigation conclusions.

• Brand Name: ENSEAL G2 CURVED JAW 35CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17324106
• Report Number: 3005075853-2023-04933
• Device Sequence Number: 6365980
• Product Code: GEI
• UDI-Device Identifier: 10705036014140
• UDI-Public: 10705036014140
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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 Model Number: NSLG2C35
• Device Catalogue Number: NSLG2C35
• Device Lot Number: A9CA5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown