MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 37CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX137C

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.The lot/ batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that during an esophagus procedure, the device worked really well at the beginning.No issues.However, the sticking started occurring after about 90 minutes.The non-fatty tissue was not easy to coag at this point verses the beginning.The device was cleaned when there was a lot of tissue.It looked like it was lacking the silicone coating, so heavy sticking occurred.The device stuck on a 6mm artery and the surgeon needed to separate the device with force.Bleeding occurred and it was clipped to address it.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 4/1/2021.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: ENSEAL X1 CURVED 37CM SHAFT
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11545916
• MDR Text Key: 241799416
• Report Number: 3005075853-2021-01531
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX137C
• Device Catalogue Number: NSLX137C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• Patient Sequence Number: 1
• Treatment: GENERATOR