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

Catalog Number	NSLG2C35
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), date sent: 5/15/2024, d4 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.
Event or Problem Description
It was reported that during a laparoscopic vaginal hysterectomy the device got stuck, unable to open or close the jaw, leaving it disabled.Change of device.The procedure was completed successfully.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/12/2024.D4 batch #: x9657z.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 bottom portion of the i blade out of the lower jaw channel; the lower jaw channel was damaged.Additionally, it was received with the cable cut off.Due to the condition of the device returned not all functional testing could be performed with the generator.The jaw was unable to cycle open and close.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.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 x9657z, and no non-conformances were identified.

• 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: 19321850
• Report Number: 3005075853-2024-03642
• Device Sequence Number: 15042573
• Product Code: GEI
• UDI-Device Identifier: 10705036014140
• UDI-Public: 10705036014140
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 05/15/2024

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: NSLG2C35
• Device Lot Number: X96C3U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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: Female