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

Model Number	NSLG2S25
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
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.The account provided 3 photo images.The first image provided by the customer is that of an enseal device.The second image is that of the distal jaw of the enseal device.A closer look at the clamp arm interface shows that the upper jaw was detached, and the iblade upper tip was broken lifted.The third image is that of the enseal upper jaw.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.A probable cause of the damage to the jaw could be not allowing thick, and fibrous tissues to denature prior to i-blade advancement.
Event or Problem Description
It was reported that during a miles surgery with uterine resection, when the surgeon sectioned the left peri-vaginal tissue, the enseal device suffered a fracture of its forceps, rendering it unusable.The event generated a fragment that was removed in its entirety.The event did not cause any harm to the patient.
Additional Manufacturer Narrative
(b)(4) date sent: 2/2/2021 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 determined that the nslg2s25 device was returned with the i-blade upper tip broken lifted and with the upper jaw detached not returned.In addition, the cable was cut off, this is not related to the complaint.Due to the returned condition of the device, no functional testing could be performed with the generator.It should be noted that product failure is multifactorial.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.

• Brand Name: ENSEAL G2 STRAIGHT JAW 25CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10734830
• Report Number: 3005075853-2020-05565
• Device Sequence Number: 1901982
• Product Code: GEI
• UDI-Device Identifier: 10705036014126
• UDI-Public: 10705036014126
• 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,Followup
• Report Date (Section B): 09/30/2020

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: 11/30/2024
• Device Model Number: NSLG2S25
• Device Catalogue Number: NSLG2S25
• Device Lot Number: U9386V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 02/02/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR; GENERATOR
• Patient Age: 55 YR