MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 45CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLG2C45
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during an unknown procedure, the tip of the jaw is detached.No patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: did the detached part fall into the patient? no information was the detached part retrieved from the patient? no information.Did this cause a change in the plan of care for the patient? no information.
Additional Manufacturer Narrative
(b)(4).Batch # r92z2l.Investigation summary: the device was received with the electrode separated from the ceramic but still attached to the active rod.In addition the jaw was firmly attached and not detached as reported.Upon visual inspection under magnification it was noted that the ceramic was partially missing.The ceramic was damaged by the separation of the electrode from the lower jaw.Testing found a short on the device when the jaws are fully or partially closed, resulting in an alert screen "reposition jaws and reactive".This is advising that the instrument is being activated on low impedance (thin) tissue or metal (such as staples, clips, retractors, or clamps).The "replace instrument" alert screen would be displayed after receiving the "reposition and reactivate" alert screen twice.The separated electrode prevented the instrument from fully cycling open or close.This is due the interference between the blade and electrode.There is insufficient evidence related to what caused the damage on the device.The batch history record was reviewed, and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: ENSEAL G2 CURVED JAW 45CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8014736
• Report Number: 3005075853-2018-14020
• Device Sequence Number: 1382415
• Product Code: GEI
• UDI-Device Identifier: 10705036014157
• UDI-Public: 10705036014157
• Combination Product (Y/N): N
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2018

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: 01/31/2023
• Device Catalogue Number: NSLG2C45
• Device Lot Number: R92J2D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 11/19/2018; 10/23/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 12/06/2018; 01/17/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR