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

Catalog Number	NSLG2S35A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the new articulated model which does not open or close the jaw.It performs the movement with great difficulty since it enters the cavity.The difficulty is observed.The dr.Tries to cut the tissue but seeing that it is not safe to close the jaw request to change the device.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/23/2024.D4 batch #: x94m60.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 determined that the device was received with skiving of the heat shrink (shaft cover) material.All of the heat shrink material appeared to have been returned.In addition, the blade was noted partially advance.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.The instrument was disassembled to verify the condition of the internal components and it was found the rod knife broken at the articulation area.The ifu warns "prior to inserting or removing the device from the trocar, ensure that the device is in the straight, non-articulated position by confirming that the indicator arrow on the articulation wheel is aligned with the top of the instrument." the ifu also warns the user to discontinue use if black heat shrink covering is damaged.A probable cause of the damage 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.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 x94m60, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: ENSEAL G2 ART STRA SEALER 35CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20048720
• Report Number: 3005075853-2024-06248
• Device Sequence Number: 7896566
• Product Code: GEI
• UDI-Device Identifier: 10705036014515
• UDI-Public: (01)10705036014515(17)270228(10)X94P54
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K122797
• 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
• Report Date (Section B): 08/23/2024

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 Catalogue Number: NSLG2S35A
• Device Lot Number: X94P54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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