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 Hematoma (1884); No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that approximately one week after a total abdominal hysterectomy procedure the patient returned to the er and a 500 cc hematoma was discovered and drained.It was stated that it is possible that the hematoma was abscessed.The surgeon stated that he had seen more oozing and bleeding during the procedure and thought that the device was not sealing well enough.

• 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: 7433924
• MDR Text Key: 105637169
• Report Number: 3005075853-2018-09152
• 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
• Type of Report: Initial
• Report Date: 03/21/2018

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: 03/21/2018
• Initial Date FDA Received: 04/16/2018
• 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