MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 25CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLG2C25
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u93g1u.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 nslg2c25 device was returned with the bottom portion of the i blade out of the lower jaw channel; the lower jaw channel was damaged.In addition, it was returned with the upper jaw detached and not returned.The device was connected to the generator and it was recognized.Because of the condition of the device 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 part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Photo analysis: this is a analysis for a set of images submitted to ethicon endo surgery for evaluation.Image 1 & 2 & 3 : the images provided by the account is that of an nslg2c25 shaft with the upper jaw damaged.Image 4 : the image provided by the account is that of an nslg2c25 shaft with the upper jaw damaged.In addition the retention pin can be seen broken.Image 5 : the image provided by the account is that of an nslg2c25 a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during the retro peritoneal resection procedure by surgeon a new 25 cm curved tip forceps was opened to use.In the procedure.It worked with around 3 - 4 activations of normal energy.But when the jaws were activated again, they no longer opened, apparently the jaws and the blade were locked, they were treated until they could be opened but later they no longer wanted to close and a part of the upper jaw was throne.Another device was used to finish the procedure.There were no patient consequences.

• Brand Name: ENSEAL G2 CURVED JAW 25CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12391514
• Report Number: 3005075853-2021-05137
• Device Sequence Number: 4105407
• Product Code: GEI
• UDI-Device Identifier: 10705036014133
• UDI-Public: 10705036014133
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 01/26/2025
• Device Model Number: NSLG2C25
• Device Catalogue Number: NSLG2C25
• Device Lot Number: U93L1U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/31/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR