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

Model Number	NSLG2S25
Medical Device Problem Codes	Device Alarm System (1012); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch: # v9663u.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch/lot.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 a hysterectomy procedure the product presented failure at the beginning of use, the blades should be re positioned, and later, halfway through the surgery, the upper part of the jaw came off completely, no force or pressure was applied and it came off completely.Just separate from the rest of the clamp.There was no delay of surgery and the procedure was successfully competed.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4) date sent: 10/24/2022 this is an analysis of a set of images submitted to ethicon endo-surgery for evaluation.Image 1 (78ed67a633c8_y4lfomfe.Jpeg): the image provided by the customer shows an enseal device with the upper jaw missing.Image 2 (247209739ed0_80mgcniy.Jpeg): the image provided by the customer shows a "reposition jaws and reactivate" alert screen displayed by a generator.Image 3 (d3fa609e438d_8mc60jik.Jpeg): the image provided by the customer shows the detached upper jaw.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslg2s25 device was returned with the upper jaw detached and not returned.In addition, the top of the i-blade was fractured and 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.No alert screens were displayed at any time during testing.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.As described in the ifu: do not use excessive force on the closing handle to close the jaws; grasp only as much tissue as will fit between the jaws where the current will pass.Greater amounts of tissue require more closing handle force.Excessive force could damage the device.Please reference the instruction for use for more information: as part of the quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: ENSEAL G2 STRAIGHT JAW 25CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 15546483
• Report Number: 3005075853-2022-06706
• Device Sequence Number: 12160807
• Product Code: GEI
• UDI-Device Identifier: 10705036014126
• UDI-Public: 10705036014126
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: NSLG2S25
• Device Catalogue Number: NSLG2S25
• Device Lot Number: V96A0E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 10/08/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown