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

Model Number NSLX137C

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 6/1/2023 d4 batch #: unknown.Additional information was requested and the following was obtained: what was the indication for the hysterotomy? it was stated the patient had to be converted to an open procedure because device would not seal the bleeder.At what point in the procedure did the sealing issue occur? after the applied gelport was secure in the sils procedure the bleeder occurr on the left side of the patient in the uterine artery area.Did the device successfully seal prior to these 3 attempts? yes, but mostly used to take down avascular tissue to get to the vascular area(s) what vessel was the device was being used on when the sealing issues occurred? not sure but in the uterine artery area.How big was the vessel? unknown.Was the device fully latched during the 3 attempts? yes.Did the device complete the sealing cycle on each attempt? yes.Were any alert screens or tones noted during the procedure? none that i saw.Is the generator log available for engineering review? unknown.Was the patient on any anti-coagulation medication prior to the procedure? unknown.What is the patient's current status? i trail had to have blood transfusion but unknown post op.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 who was in the case that during a single incision laparoscopic hysterectomy procedure that the device was not sealing the vessel.Surgeon attempted three times to control the bleeding.The procedure was converted to open; patient is receiving a transfusion and the surgeon used suture and electro cautery to control the bleeding.

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17038284
• MDR Text Key: 316310559
• Report Number: 3005075853-2023-03646
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• 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: 06/01/2023

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: X96C1F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention