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

Catalog Number NSLX120L

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk the lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that on (b)(6) 2017 a vaginal hysterectomy was performed using enseal x1 which was uncomplicated.There were no sutures used for any of the pedicles and the only suture was vicryl to close the vault at the end of the procedure.The patient made good recovery in the immediate postoperative period and was discharged home the following day.A few weeks later she represented in a different hospital with right loin pain with worsening renal functions.It became apparent that she had right ureteric injury and required re implantation of the right ureter on (b)(6) 2018.She is said to be making good recovery and both kidneys are functioning well.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7488332
• MDR Text Key: 107399884
• Report Number: 3005075853-2018-09575
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: NSLX120L
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention