MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 LARGE JAW TISSUE SEALER; ELECTROSURGICAL CUTTING AND COAGULATING DEVICE

Catalog Number NSLX120L

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p9339v.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information requested and the following was obtained: did the patient have the loss of blood due to the issues with this device? yes, since the devices was not working properly (with the errors) the sealing was not completed in its full capacities , which leads to the bleeding did the patient receive any blood or blood products? no.I put blood.The control after was 8.9.And did not present hemodynamic changes.And the last control today is 9.3.Albumin was only given to help improve the volume and not affect the kidney when was the patient given the albumin? at the end of the surgery, when we had already closed, to help the intravenous volume.

Event Description

It was reported that during an open hysterectomy procedure, the enseal x1 device only worked well the first 15 minutes of the surgery, and then showed the failure of re-position the jaws.It was done.To continue the procedure the doctor took less tissue, but again the message was shown.Subsequently it requested to clean the jaws, and a subsequent use was attempted.The message to re-position the jaws was shown again.The device was turned on and off, it worked for one activation, and then again the error message appeared.This happened about 4 times, the doctor requested another x1 to continue the surgery, since it was a complex case and the patient had already lost almost 1 liter of blood.The new x1 used in the rest of the surgery worked well without any errors.Final consequences: patient hemoglobin was low, in 9.

Manufacturer Narrative

(b)(4).Batch # p9339v.Device received, analysis isn¿t complete.

Manufacturer Narrative

(b)(4).Batch # p9339v.Investigation summary: the device was tested on the generator and received a ¿close jaws and reactivate¿ error message.The ¿replace instrument¿ alert screen was displayed after receiving two consecutive alert screens and is advising of a potential issue with the instrument.The investigation of the device did not confirm the ¿reposition jaws and reactivate¿ error reported.Further investigation of the device eeprom confirmed that "close jaw and reactivate" and "replace instrument" error messages were encountered during the procedure.The "close jaw and reactivate" error message was encountered 17 times during the procedure and the device was re-plugged into the same generator, 4 additional times.The device was disassembled and it was observed that the return contact was splayed and the shroud around the contact had heat damage.Repeatedly re-plugging the device into the generator and restarting the generator after receiving the error messages may have caused additional damage to the return contact and the shroud.Additionally, material spectral testing was performed on the return contact and the shroud to rule out any presence particulate in the area.No evidence of particulate (saline) was found on or around the contact.After the investigation the cause was found to be a splayed return contact and repeated use of the device after encountering generator alert messages caused additional damage to the contact and the adjacent shroud.It is advised that generator alerts not be over written and appropriately replacing the device if and when prompted.The batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: ENSEAL X1 LARGE JAW TISSUE SEALER
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATING DEVICE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7550968
• MDR Text Key: 109558104
• Report Number: 3005075853-2018-10221
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20705036015021
• UDI-Public: 20705036015021
• Combination Product (y/n): N
• PMA/PMN Number: K160554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: NSLX120L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/14/2018; 05/14/2018
• Supplement Dates FDA Received: 06/19/2018; 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1