MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 LARGE JAW TISSUE SEALER; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX120L

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: " during initial surgical procedure, were the short vessels skeletonized or were they taken with mesentery? unknown " were there any alert screens during the initial procedure? no " were there any issues with the device in the initial procedure? no " did the surgeon hear the completion tone for every cycle? yes " did any oozing, bleeding, or hemostasis issues occur during the initial procedure? no " how soon after the initial surgical procedure was the bleeding identified? withing 12 hours " were there any precipitating events, such as coughing, etc., indicating an issues prior to the coding and re-operation? unknown " what was done in the second surgical procedure to address the bleeding? sutured the vessels " how many units of blood were given to the patient? surgeon doesnt remember " what is the patient's current status? good 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 Description

It was reported that during a esophagectomy procedure in combination with a pancreatic procedure the short gastric were sealed and transected with the x1 device.The patient was in a recovery unit when they began coding.The patient was taken back to surgery and the short gastric were found to be bleeding.The patient was transfused and is doing fine.

• Brand Name: ENSEAL X1 LARGE JAW TISSUE SEALER
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 11117593
• MDR Text Key: 225101730
• Report Number: 3005075853-2021-00037
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: 10705036015024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX120L
• Device Catalogue Number: NSLX120L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention