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

Catalog Number	NSLG2C45
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information requested but unavailable: did the surgeon attempt to manually open the jaws with his fingers? if no: was the device on a vessel/artery when it would not open? if yes, how was the device removed? (i.E.Cut off, forced opened)? if cut off, did this cause a change in the plan of care for the patient? did the removal cause any damage to the vessel/artery? if yes, what is the damage and how was the damage repaired? did the surgeon continue the case with this same device?.
Event or Problem Description
It was reported that at an unknown time the jaws of the device would not open.It is unknown if there were any adverse patient consequences.

• 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: 8855316
• Report Number: 3005075853-2019-20985
• Device Sequence Number: 11238894
• Product Code: GEI
• UDI-Device Identifier: 10705036014157
• UDI-Public: 10705036014157
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: 04/30/2024
• Device Catalogue Number: NSLG2C45
• Device Lot Number: T93628
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/02/2019
• Patient Sequence Number: 1