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

Model Number	NSLG2S45
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #t94l6v.Investigation summary: the device was returned with the upper jaw detached, broken and returned.The device was connected to the generator and it was recognized.Because the jaw was detached, not all functional testing could be performed with the generator.The condition of the jaws prevented the functionality of the jaw.The device was unable to cycle open and close.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/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 laparoscopic sigmoid colectomy, the jaws of the device would not close completely, and the tip of the jaw broke off and fell into the patient.The tip was found and removed from the patient.The procedure was completed with a like device with no patient consequences.

• Brand Name: ENSEAL G2 STRAIGHT JAW 45CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9851110
• Report Number: 3005075853-2020-01697
• Device Sequence Number: 764648
• Product Code: GEI
• UDI-Device Identifier: 10705036014195
• UDI-Public: 10705036014195
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 09/30/2024
• Device Model Number: NSLG2S45
• Device Catalogue Number: NSLG2S45
• Device Lot Number: T94G1X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/18/2020
• Patient Sequence Number: 1