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

Model Number	NSLG2C25
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: did the electrode ceramic separate or break off? => it was only reported that the tip broken.Did the i blade get damaged or break off? no further information will be available.Is the jaw damaged but not broken off? the tip of the jaw broken off.No further information will be available.Is the top jaw loose but not detached? no further information will be available.Is the top jaw ptc material damaged? no further information will be available.Is the black ptc in the upper jaw detached? no further information will be available.Is the top jaw broken off the of the device? no further information will be provided." 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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that, during an open urological surgery, the tip of the jaws broke when cleaning.No pieces fell into the patient.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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 ; * 00969
• MDR Report Key: 11627497
• Report Number: 3005075853-2021-01808
• Device Sequence Number: 16983200
• 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
• Report Date (Section B): 03/16/2021

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 Model Number: NSLG2C25
• Device Catalogue Number: NSLG2C25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR