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

Catalog Number NSLX137S

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

Patient Problems Hemorrhage/Bleeding (1888); Multiple Organ Failure (3261)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/25/2023.D4 batch #: a9c74h.Additional information was requested and the following was obtained: product: enseal x1 tissue sealer.Lot: a9c74h.Replaced with a ligasure.Procedure: laparoscopic hysterectomy bilateral salpingectomy.Tissue type device was used: adhesions, uterine/vaginal/fallopian tubes.Event occurred over halfway through case and device was used on fallopian tubes.Did the generator display any error messages and if so what were they? according to the surgeon, the generator made all the same sounds as it always does.No error messages occurred.Did the device pass the pre-test? yes.Had the device been working and then stopped? yes.It took down adhesions and one side of fallopian tubes before the incident occurred.Did the electrode ceramic separate or break off? unknown.Did the i blade get damaged or break off? unknown.Is the jaw damaged but not broken off? unknown.Is the top jaw loose but not detached? unknown.Is the top jaw ptc material damaged? unknown.Is the black ptc in the upper jaw detached? unknown.Is the top jaw broken off the of the device? unknown.Did the patient experience any adverse consequences due to this issue? yes.Due to bleeding not being able to controlled, the patient lost the ovary on that side.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 was the surgical procedure? what is the surgeon's experience with the device? does the surgeon use a single burn or double burn technique? did the bleeding issues happen intra-op or post-op? what was the source of the bleeding? was device used to seal the source of the bleeding? what was the approximate size of vessel that was bleeding? what was the total amount of blood loss? was a blood transfusion required? how was the bleeding controlled? were there any generator alert screens? can it be confirmed that the surgeon latched the device with each firing? can it be confirmed that the surgeon received the end tone prior to transection with each firing? is a video of the procedure available for ethicon review? 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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.A manufacturing record evaluation was performed for the finished device batch 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 that during a laparoscopic hysterectomy bilateral, after taking down multiple adhesions and cutting/coagulating one fallopian tube, doctor went to other fallopian tube to do the same cut/coag.Machine/generator made the normal sounds, unclamped tissue & patient's tube bleeding.Unable to control with multiple attempts with enseal to coag tissue.Opened a ligasure laparoscopic maryland and was able to control bleeding on 2nd attempt.Unfortunately, the patient lost that ovary due to the uncontrolled bleeding that the enseal couldn't stop.

Manufacturer Narrative

(b)(4).Date sent: 9/28/2023.D4 batch #: a9c74h.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the device was received with no apparent damage.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All tones were heard during functional testing.The device was tested with the test media and no anomalies were found.There were no anomalies noted with the functionality of the device.A manufacturing record evaluation was performed for the finished device batch number a9c74h, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.

• 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: 17624347
• MDR Text Key: 321960953
• Report Number: 3005075853-2023-06090
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.
• Patient Outcome(s): Required Intervention