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

Model Number	NSLG2S14
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.
Event or Problem Description
It was reported that during an unknown procedure, the nslg2s14 enseal tissue sealer g2 jaw was unable to open.Hcp has to forced open the jaw.Hcp complained that there was crush sound during closing the jaw.After retrieve the shears, she found there was a cracked at the closing handle.No patient consequence.
Additional Manufacturer Narrative
(b)(4).D4: batch # m90m04.Investigation summary: this is an evaluation of the picture provided by the account and not of the actual instrument.  image 1: the image provided by the account is that of a enseal tigger where the batch can be seen as m90m04.Image 2: the image provided by the account is that of an nslg2s14 device where the device appear to be closed on gauze.The gauze stuck is a routine occurrence during surgical procedures.If the device is used across gauze, staples, clips or any other material then tissue, this does not necessarily indicate a manufacturing defect in the device.Care should be taken not to close the jaw on gauze, staples, clips or any other material than tissue, for further information on device use can be found on the ifu.However, due to the instrument was not return our evaluation is limited.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.

• 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: 9875573
• Report Number: 3005075853-2020-01790
• Device Sequence Number: 14180649
• Product Code: GEI
• UDI-Device Identifier: 10705036014171
• UDI-Public: 10705036014171
• 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
• Report Date (Section B): 03/03/2020

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: 05/01/2020
• Device Model Number: NSLG2S14
• Device Catalogue Number: NSLG2S14
• Device Lot Number: M4HM2U
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 06/09/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR