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

Catalog Number NSLG2C45

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 04/16/2018

Event Type  Injury  

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 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.

Manufacturer Narrative

(b)(4).On (b)(4), the correct complaint number is (b)(4).

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
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7503261
• MDR Text Key: 107881739
• Report Number: 3005075853-2018-09751
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20705036014154
• UDI-Public: 20705036014154
• Combination Product (y/n): N
• PMA/PMN Number: K112033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 04/18/2018
• Supplement Dates FDA Received: 05/10/2018; 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention