MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 25CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX125C

Device Problems Material Integrity Problem (2978); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: u94v5v.Additional information was requested and the following was obtained: what is the patient current health status? no further information will be available.Did the procedure have to be converted to open? no further information will be available.The surgeon think the dehiscence of the sealing part was caused by the burned jaw surface.As a result, the bleeding occurred.And also, he had no good impression of the x1 curved device.The patient had low blood pressure and suffered from anemia.The patient is recovered from the anemia, but the other complication was confirmed.The detail of the complication was asked of the surgeon, but he said the complication was not related to the device and he could not say anything.The patient is going to stay longer in the hospital.Was the bronchial artery skeletonized or ligated within a tissue bundle? yes, the bronchial artery was skeletonized appropriately and it was ligated if necessarily.What was the approximate compressed width of the bronchial artery? the sales rep could not obtain the information from the surgeon.During the sealing process for this vessel, was anything unusual experienced? => there was no different experiences.Were any alert screens displayed on the generator? there was no any alarm message on the generator.Were there any difficulties with the device? no, but the surgeon was concerning the sticking tissue from the first half of surgery.The sales rep advised to clean up the tip of the device frequency.He completed the procedure with only the device.He did not use any electrical cautery.And also, he did not use an anti-stick product from third party.Were there any abnormalities with the physical characteristics of the device? no.How was the anemia addressed? it was just monitoring.The anemia was improved quickly after operation.Were blood products administered? no.What is the patient's current status? the patient was confirmed other complication.The sales rep asked the surgeon detail information, but the surgeon did not answer.However, the surgeon think the complication was not related to the device.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.

Event Description

It was reported that, during a laparoscopic right lower lobectomy, bleeding occurred from the bronchial artery after the seal was released.The amount of bleeding was about 850cc and a blood transfusion was not performed.Astriction was performed and the electric knife was used to stop the bleeding.To make sure the bleeding stopped, ligation and clips were used too.The surgeon commented that this issue may not be the device fault.The device was used on the blood vessels.The device was used as is to complete the case.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 6/28/2021.This is a analysis for a set of images and video submitted to ethicon endo surgery for evaluation.Image1: the image provided by the customer is that of what appears to be an enseal device.Video: the video provided by the customer is that where it can bee seen what appear to be a enseal device been used.During the video it can be observed a leakage once the device is removed from the tissue.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached as to how this issue occurred through photo analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslx125c device was received with no apparent damage.No damage was observed at the jaws as reported.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.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event.Please reference the instruction for use for more information.The event described could not be confirmed as the device performed without any difficulties noted and no cartridge was returned for analysis.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: ENSEAL X1 CURVED 25CM SHAFT
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11957773
• MDR Text Key: 256482606
• Report Number: 3005075853-2021-03173
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015444
• UDI-Public: 10705036015444
• Combination Product (y/n): N
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/16/2021

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: NSLX125C
• Device Catalogue Number: NSLX125C
• Device Lot Number: U94V5V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 05/16/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 06/28/2021
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention