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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported who found the device in the facility¿s defective device bin that the device was tagged ¿device malfunctioned during case¿ ¿closed on staple and wouldn¿t re-open¿ no further information was provided.There were no adverse consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/10/2023.D4 batch #: x95y3v.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 skiving of the heat shrink (shaft cover) material.All of the heat shrink material appeared to have been returned.Additionally, it was received with minor yielding on the articulation joint.Upon visual inspection, a tissue was observed stuck in the jaw causing an open issue.In addition, the lower jaw was noted to be bent.Not all functional testing could be performed as the condition of the device returned.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.It is possible that this type of damage to the articulation can occur after the device undergoes heavy loading and could have contributed to the reported event.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: 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 manufacturing record evaluation was performed for the finished device batch x95y3v, and no non-conformances were identified.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16583316
• Report Number: 3005075853-2023-01763
• Device Sequence Number: 17317014
• Product Code: GEI
• UDI-Device Identifier: 10705036014553
• UDI-Public: 10705036014553
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: NSLG2C45A
• Device Catalogue Number: NSLG2C45A
• Device Lot Number: X9609H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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