MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 45CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLG2C45
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.Additional information was requested and the following was obtained: was the source of the bleeding solely the short gastric artery or were there other structures determined to be the source of the bleed? yes, the short gastric artery.Were there any other patient factors that may have contributed to the bleeding? the surgeon said no.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during a sleeve gastrectomy procedure, the surgeon was looking to transect the short gastric artery close to the spleen.The enseal was closed and all tones were heard.When the device was opened it had cut the vessel but not sealed it.A vascular surgeon was called in to assist.The patient was opened to control the bleeding but the procedure was completed laparoscopic.The patient ended up losing large volume of blood, 3.5 l.The patient was transferred to icu for 24 hrs.
Additional Manufacturer Narrative
(b)(4).On (b)(4), the correct complaint number is (b)(4).
Additional Manufacturer Narrative
(b)(4).Batch # p93j5y.Investigation summary: the device was received with the cable cut off and energy button detached.The energy button was not returned with the device.Due to the returned condition of the device, no functional testing could be performed with the generator.However, the device was mechanically tested and no anomalies were noted.In addition we were unable to investigate further the reported tissue and hemostasis issues reported due to the returned device condition.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment the batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: ENSEAL G2 CURVED JAW 45CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7503261
• Report Number: 3005075853-2018-09751
• Device Sequence Number: 284343
• Product Code: GEI
• UDI-Device Identifier: 20705036014154
• UDI-Public: 20705036014154
• 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,Followup
• Report Date (Section B): 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: NSLG2C45
• Device Lot Number: P93M28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018; 04/18/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 05/10/2018; 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention