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

Model Number	NSLG2S45A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u95r2e.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Additional information was requested, and the following was obtained: did the electrode ceramic separate or break off? did the i blade get damaged or break off? is the jaw damaged but not broken off? is the top jaw loose but not detached? is the top jaw ptc material damaged? is the black ptc in the upper jaw detached? is the top jaw broken off the of the device? answer = sorry; i was not in the case.I only handle the return and receiving of the product.Thanks.
Event or Problem Description
It was reported that during an unknown procedure the jaws broke into two pieces.Both pieces were retrieved.The procedure was completed with a like device with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/16/2021.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslg2s45a device was returned with the upper jaw detached and not returned.In addition, it was received with the top of the i-blade fractured and slightly lifted.Also, the black heat shrink covering (shaft cover) was damaged.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.It should be noted that product failure is multifactorial.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.Please reference the instruction for use for more information.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.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: ENSEAL G2 ART STRA SEALER 45CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11359532
• Report Number: 3005075853-2021-00992
• Device Sequence Number: 4117409
• Product Code: GEI
• UDI-Device Identifier: 10705036014560
• UDI-Public: 10705036014560
• Combination Product (Y/N): N
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 10/31/2025
• Device Model Number: NSLG2S45A
• Device Catalogue Number: NSLG2S45A
• Device Lot Number: U95R2E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR; GENERATOR