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

Model Number NSLX120L

Device Problems Activation, Positioning or Separation Problem (2906); Appropriate Term/Code Not Available (3191)

Patient Problem Failure to Anastomose (1028)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unknown.(b)(4).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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Additional information was requested, and the following was received: what were the indications for surgery? low anterior resection.Where was the site of the leak? what was the location where the circular stapler was used or the enseal device? unknown.Was there thermal damage near or at the site of the leak that would be correlated to the enseal device? unknown.Does the surgeon believe that the leak and infection is associated to the enseal device? if yes, why? yes, improper sealing.Does the surgeon believe that the leak and infection is associated to the cdh29p device? if yes, why? unknown.Did the patient receive any preoperative chemotherapy or radiation? no.Were there any issues experienced with the device in the initial surgical procedure? no.What healthcare professional fired the device and what is his/her experience with the device? resident.Where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? low-b.Did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? unknown.Were there any issues with device use/firing? when using enseal i-blade would jump, i believe due to improper technique of using device.What confirmation was received that the device completed the firing sequence? unknown.Was the green checkmark visible at the end of the firing? yes.How many counter-clockwise revolutions of the adjusting knob were used to open the device? two.Was there any difficulty removing the device? unknown.Was a complete transection of the white breakaway washer visually confirmed? unknown.Were the donuts inspected? if so, please describe.Yes.Were there any issues noted with staple formation? if so, please describe the shape and location.Unknown.Was a leak test performed? if so, what type and what was the result? yes, unknown.Was the staple line visualized endoscopically during the initial surgical procedure? no.How many days postoperative did the leak occur? 2-3 days.How was the leak identified? unknown.What was observed at the site of the leak upon reoperation? unknown.How was the leak addressed? unknown.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that post-op patient had an anastomotic leak/surgical site infection after colorectal case.

• 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 ; * 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 11365216
• MDR Text Key: 233243949
• Report Number: 3005075853-2021-01036
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: 10705036015024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX120L
• Device Catalogue Number: NSLX120L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention