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? within about 4 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 to ligate bleeding vessels.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.

Event Description

It was reported, during a paraoesophageal hernia, the short gastric were transected and sealed with enseal.The patient later coded in the patient care unit and was taken back to surgery.When they opened the patient, they found that the short gastric were bleeding.The patient was given four units of blood and surgeon sutured the short gastric to stop the bleeding.The patient is currently in the icu but stable.

• 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: 11117457
• MDR Text Key: 226106484
• Report Number: 3005075853-2021-00036
• 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
• Patient Outcome(s): Required Intervention