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

Model Number	NSLG2S25
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.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 a parauterine intake, more or less 45 minutes into surgery, a small noise occurred and they saw that one of the branches of the jaw was missing.They looked for it inside the patient and found it at one of the edges of the field.They report that nothing unusual was done.Upon realizing it, they continued with the usual instruments and asked for another to do the lymphadenectomy and omentectomy.Surgery was delayed 15 minutes and was successfully completed.Fragments were generated, but were easily removed without additional intervention.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/23/2020.Investigation summary: 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 and the manufacturing criteria were met prior to the release of this lot/batch.

• 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
• MDR Report Key: 10075725
• Report Number: 3005075853-2020-02678
• Device Sequence Number: 2916828
• Product Code: GEI
• UDI-Device Identifier: 10705036014126
• UDI-Public: 10705036014126
• 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): 04/28/2020

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: 03/31/2021
• Device Model Number: NSLG2S25
• Device Catalogue Number: NSLG2S25
• Device Lot Number: N90Z0L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR