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

Catalog 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 01/01/2023

Event Type  Injury  

Event Description

It was reported that dr.Was performing an lavh using the nslx137c for the laparoscopic portion of the case and a ligasure 1212a for the vaginal portion.The enseal was used several times for dissection, grasping, and transection of tissue bundles.During these activations, the enseal activated as noted by the energy cycle tone and energy completion message on the generator gen11.In addition, the tissue between the jaws of the enseal device also began to show signs of energy activation, tissue blanching around the device's jaw.There were a few firings of the enseal where dr.Used one complete energy cycle before the transaction.On the whole, dr.Performed two full energy cycles before transecting.Upon the transection of the tissue bundles with the enseal, ethicon sales representative, observed the complete sealing of the tissue with no apparent bleeding.On one occasion, dr.Asked for suction to observe a transection better.The tissue was irrigated, and no bleed was seen.There was one transaction that resulted in a bit of blood oozing.He clamped the enseal on it, activated two complete energy cycles, and transected further following the plane of dissection he was completing.Dissection of the bladder flap was also done with the enseal device, and no bleeding was noted.Further surgical site irrigation was completed, and no signs of bleeding or incomplete transactions were observed.The case progressed to the vaginal portion, and the ligasure 1212a was used.After this point, there was a 60 minute delay.There was patient harm.

Manufacturer Narrative

(b)(4).Date sent: 10/5/2023.B3: event year only reported: 2023.D4 batch #: unknown.Additional information was requested and the following was obtained: is it the surgeon¿s standard procedure to use both the enseal device and ligasure device for an lavh case, or were there any patient factors that influenced the decision to used both the enseal and ligasure device? yes what is the patient¿s current status? discharged if the patient harm was bleeding, please answer the following questions: what was the source of the bleeding, and was it where the enseal was used? uterine arteries, utero-ovarian pedicles, round ligament.Yes when did the bleeding occur? noted after specimen removed vaginally were there any device issues identified during operation that led to the bleeding? none noted how much blood loss was there? pre-surgery h&h 13.8/40.4, intra-op 8.6/26.4 did the patient require a blood transfusion? yes.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 number, and no non-conformance 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.

• 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: 17875618
• MDR Text Key: 324970620
• Report Number: 3005075853-2023-07239
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSLX137C
• Device Lot Number: X9555U
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention