MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 37CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX137C

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/12/2022.Batch #: v95d1p.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: what anatomical structures was the device used on in the initial procedure? were there any difficulties with the device in the initial procedure? were there any generator alert screens in the initial procedure? how was the bleeding identified? what was the site of the bleeding? was the site of the bleeding an area where the enseal was used in the initial procedure? what was the estimated blood loss? were any blood products administered? how was the bleeding addressed? what is the patient's current status? an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 a patient was brought back to theatre due to bleeding - possibly cardiac arrest - after sleeve gastrectomy.The bleeding was controlled and patient ok at the moment.

• Brand Name: ENSEAL X1 CURVED 37CM SHAFT
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (CINCINNATI)
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15221689
• MDR Text Key: 297859236
• Report Number: 3005075853-2022-05275
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2022

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: NSLX137C
• Device Catalogue Number: NSLX137C
• Device Lot Number: V95D1P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention