MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 25CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLG2C25
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: t93m39.Additional information was requested and the following was obtained: did the patient suffer any adverse consequences? no, the patient did not suffer from it.Was part of the i-blade damaged or broken off? it looked broken off.If yes for broken off, did any part fall into the patient? no, there were nothing on x-ray result.If yes for fallen into the patient were all pieces retrieved? no, they were not retrieved.Were any pieces left in the patient? no, there were nothing on x-ray result.If yes, what plans are there to remove the pieces from the patient? the patient was taken detailed x-ray, but there were not any parts of i-blade.What is the current condition of the patient? the patient has been good.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.Complaint information is trended on a regular basis to determine if further investigation is warranted.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during an unknown procedure, after the blade of the enseal device went forward, it did not come back and stuck in the blade rail.It seemed to be broken off.The surgeon took the device out from a patient.A scrub nurse cleaned the jaw and seemed to see the part of the blade.The patient had an x-ray test, but there appeared to be no fragments in the patient.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/1/2020.Device evaluation: the device was returned with the bottom portion of the i blade out of the lower jaw channel; the lower jaw channel was damaged.The device was connected to the generator and it was recognized.Because of the condition of the device not all functional testing could be performed with the generator.The jaw was unable to cycle open and close.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.Photo evaluation: the images provided by the customer are that of the distal jaw of what appears to be an enseal device.A closer look at the clamp arm interface shows the iblade was at the wrong side of the jaw.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.

• Brand Name: ENSEAL G2 CURVED JAW 25CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10693210
• Report Number: 3005075853-2020-05354
• Device Sequence Number: 11745646
• Product Code: GEI
• UDI-Device Identifier: 10705036014133
• UDI-Public: 10705036014133
• Combination Product (Y/N): N
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 05/31/2024
• Device Model Number: NSLG2C25
• Device Catalogue Number: NSLG2C25
• Device Lot Number: T93M39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/01/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR