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

Catalog Number NSLX137S

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 3/6/2024 d4 batch #: unknown.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 is meant by ¿directly responsible for bladder injury¿? can an explanation of the bladder injury be provided? please describe the circumstances of how the bladder injury occurred? what heat management techniques were used throughout the procedure? what is the surgeon¿s experience with the enseal x1 device? at what stage, or portion, of the procedure was the surgeon on when the bladder injury occurred? was there any malfunction or deficiency with the device that was identified during the procedure? was the bladder injury due to a deficiency of the device? did they have to open the patient or were they able to keep the procedure as a lap to treat the bladder injury? 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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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 the surgeon claimed device was directly responsible for bladder injury to patient during a total laparoscopic hysterectomy.Hole in the bladder was sutured with vloc and had a stent placed.After a 120 minute delay the procedure was completed.

Manufacturer Narrative

(b)(4).Date sent: 3/14/2024.Additional information was requested and the following was obtained: surgeon felt the device was the cause of the bladder injury.The surgeon was in what he thought was the uterine vesicle peritoneum and was dissecting that tissue plane, and inadvertently dissected a 2cm defect into the bladder.Was not activating energy at this time.Used the jaws to dissect with end defectors.The surgeon was using the device for the 5th case, as the institution forced the transition due to contracting.There was no malfunction with the device during the procedure that were identified.Surgeon described the device as ¿working as it always has¿ and nothing malfunctioned but is an ¿inferior¿ instrument.Bladder injury was due to surgeon technique.They did not open the patient and case remained laparoscopic.Patient current status is unknown but no further steps were determined other than a cystoscope for her follow up in a week.Surgeon likely blaming device due to dislike for the instrument.

• Brand Name: ENSEAL X1 STRAIGHT 37CM SHAFT
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18846907
• MDR Text Key: 337008405
• Report Number: 3005075853-2024-01953
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015482
• UDI-Public: 10705036015482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSLX137S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• 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
• Patient Sex: Female