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 Blood Loss (2597)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information obtained: surgeon commented that the x1 seals were the source of the bleeding.The device was used on vessels, not just mesentery take-down.It is unknown if there was a blood transfusion or what was done to stop the bleeding.It was noted that there was no variation in the sealing cycle during the case.The sealing cycle was the same length of time regardless of the tissue type or texture.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that during an unknown procedure on (b)(6) 2018 the surgeon was making double and triple burns to seal tissue with the device.The generator kept displaying error messages (exact message was not provided).It was suggested that the device be replaced, however it was not and the case was completed.At 3:30 am on april (b)(6) 2018, the surgeon was called in due to the patient experiencing internal bleeding.It was discovered that the staple lines from the original procedure were intact but 60% of the seals where the device was used were blown open.As of april (b)(6) the patient was stable.

Manufacturer Narrative

(b)(4).Date sent: 6/27/2018.The event log of the generator used with the device was reviewed.The event log was not conclusive on the root cause.

• 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: 7524721
• MDR Text Key: 108607397
• Report Number: 3005075853-2018-09952
• 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,Followup
• Report Date: 04/26/2018

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: 04/26/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 06/27/2018
• 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