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

Catalog Number	NSLG2C35
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 8/9/2024.D4 batch #: a9ej2u.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information was obtained: the broken part was conductive part, not i-blade.And the device did not pinched any hard things.It was aware that there were no pieces left in the patient.They ask for check the device as soon as possible because they will deal with the patient and hospital if there is pieces left 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 received with the electrode and ceramic separated from the lower jaw but still attached to the active rod.In addition the cable was received cut off and the lower tip of the blade was noted to slightly damaged bent upon visual inspection under magnification, it was noted that the ceramic was damaged (cracked)but is still bonded to the lower jaw.The ceramic was damaged by the separation of the electrode from the lower jaw.Due to the device returned condition not all functional testing could be performed the separated electrode prevented the instrument from fully cycling open or close.This is due to the interference between the blade and electrode.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.There is insufficient evidence related to what caused the damage to the device.
Event or Problem Description
It was reported that, during laparoscopic hysterectomy, the i-blade was broken when the device pinched hard tissue.It was used on uterus.It was unknown whether there was bleeding.It was explained on the phone that the broken pieces were metal, and it is going to be checked by x-ray just in case.No pieces were left inside the patient.Another device was used to complete the case.No further information is available.

• 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 ; * 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: 19949597
• Report Number: 3005075853-2024-05868
• Device Sequence Number: 13003578
• Product Code: GEI
• UDI-Device Identifier: 10705036014140
• UDI-Public: 10705036014140
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/09/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• 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