MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 LARGE JAW TISSUE SEALER; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX120L

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 were the indications for surgery? what is the surgeon's experience with the device? when was it identified when the device wasn¿t sealing well, beginning, after a few uses, towards the end of the procedure or post op? what anatomy structure did they have the bleeding from? was the device difficult to close or open? did he wait till he heard the completion tone on the device for each transection? was the surgeon transecting with a single burn or was the surgeon using multiple burns and cutting in the middle? when was the blood transfusion administered? was the post op care of the patient altered as a result of the difficulty use of the device?.

Event Description

It was reported that in a tah, had a giant uterus.Surgeon said device x1 wasn't sealing well.Surgeon said because of lack of sealing power, throughout case, patient lost more blood than needed and patient received two transfusion units.Resorted to using suture.The procedure with no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 6/8/2020.Investigation summary the device was received with the cable cut off.Due to the returned condition of the device, no functional testing could be performed with the generator.However, the device was mechanically tested and no anomalies were noted.The cable cut off is not related with the reported "hemostasis issues, tissue effect issues" therefore we are unable to investigate further the reported issues.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional information was requested and the following was received: what were the indications for surgery? unknown but was a tah what is the surgeon's experience with the device? intermediate when was it identified when the device wasn't sealing well, beginning, after a few uses, towards the end of the procedure or post op? after a few uses what anatomy structure did they have the bleeding from? na was the device difficult to close or open? no did he wait till he heard the completion tone on the device for each transection? i was no in the case but surgeon said yes was the surgeon transecting with a single burn or was the surgeon using multiple burns and cutting in the middle? surgeon was using double burn technique as she is a former impact user when was the blood transfusion administered? yes.Was the post op care of the patient altered as a result of the difficulty use of the device?.

• Brand Name: ENSEAL X1 LARGE JAW TISSUE SEALER
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10124097
• MDR Text Key: 194163217
• Report Number: 3005075853-2020-02876
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: 10705036015024
• 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
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: NSLX120L
• Device Catalogue Number: NSLX120L
• Device Lot Number: T92343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Date Manufacturer Received: 05/12/2020
• Patient Sequence Number: 1
• Treatment: GENERATOR; GENERATOR
• Patient Outcome(s): Required Intervention