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

Model Number NSLG2C35

Device Problems Material Integrity Problem (2978); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported that, during an ob-gyn procedure, an unexpected sound was heard, and a part of the blade was broken off outside the patient.The broken piece has been retrieved.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Batch #: x94a5z.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 nslg2c35 device was received with the lower tip of the i-blade broken and the piece was returned.In addition, cracks in the trigger were noted.The device was connected to the generator and it was recognized.Because the i blade was damaged not all functional testing could be performed with the generator.The jaws were found attached to the instrument.In addition, no pieces were found missing under microscope inspection.The condition of the blade prevented the functionality of the jaw.The jaw was unable to cycle open and close.A probable cause of the damage to the i blade 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.The noise reported may have been the iblade when it was damaged.It is possible that the damage to the trigger was caused by excessive force when trying to close it.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.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.

• Brand Name: ENSEAL G2 CURVED JAW 35CM
• Type of Device: 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15248931
• MDR Text Key: 305171198
• Report Number: 3005075853-2022-05389
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036014140
• UDI-Public: 10705036014140
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLG2C35
• Device Catalogue Number: NSLG2C35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR