MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 STRAIGHT JAW 14CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLG2S14
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r92543.Investigation summary : the device was returned with the upper jaw detached and not returned.In addition, the i-blade was slightly lifted.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.Therefore, we were unable to investigate further the alert screen and the instrument error issues reported.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
Event or Problem Description
It was reported that when connecting the enseal to the gen11, the generator recognized it as usual, but later it began to indicate that there was an error in the blades, and that they had to be separated.Then the gen11 asked to disconnect the product.The product was disconnected and reconnected.When trying to use the enseal, the jaw broke when using it on the abdominal wall.The movable claw of the clamp was the one that broke and fell in the patient, this piece was removed by the doctor, the patient was not hurt at any time.There was no damage to the patient, the surgery was performed with silks, as there were no more devices available.

• Brand Name: ENSEAL G2 STRAIGHT JAW 14CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8771996
• Report Number: 3005075853-2019-20284
• Device Sequence Number: 1845507
• Product Code: GEI
• UDI-Device Identifier: 10705036014171
• UDI-Public: 10705036014171
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 07/08/2019

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: 12/31/2022
• Device Catalogue Number: NSLG2S14
• Device Lot Number: R92543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/09/2019
• Patient Sequence Number: 1