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

Model Number	NSLG2S35
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the jaw of the product was broken.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/2/2023.B3: event year only reported: 2023.D4 batch #: x95320.Additional information was requested and the following was obtained: "it was reported that the upper jaw of the product was fractured during the surgery.Since the case was continued by opening a spare product, no adverse events occurred in the patient.".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 returned with the upper jaw detached and not returned.In addition, the i-blade was with the top of the i-blade fractured and slightly lifted the device was connected to the generator and it was recognized.Because the jaw was detached not all functional testing could be performed with the generator.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: as part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch#: x95320, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/8/2023.Additional information was requested and the following was obtained: the device was returned with a missing piece.The missing piece is the upper jaw.Does the customer know what happened to the missing piece? if yes, please describe.The customer knows about the missing piece.The piece wasn't collected from the operation table due to not paying enough attention.It wasn't provided to the sales rep.

• Brand Name: ENSEAL G2 STRAIGHT 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: 17053603
• Report Number: 3005075853-2023-03757
• Device Sequence Number: 19696574
• Product Code: GEI
• UDI-Device Identifier: 10705036014188
• UDI-Public: 10705036014188
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: NSLG2S35
• Device Catalogue Number: NSLG2S35
• Device Lot Number: X9594Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2022
• 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