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

Model Number NSLX137C

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Peritonitis (2252)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: ¿ noted that it was a gastric procedure, can we confirm what was the specific procedure? the procedures were all laparoscopic sleeve gastrectomy how was it completed? laparoscopically patient status if known? no adverse advents for any of the three patients.Which part of the procedure was the enseal used in? mobilising the greater curvature of the stomach before stapling of the gastric tissue.Did gastric contents actually spilled during removal or was it just a concern due to the reported issue.Gastric contents spilled as the specimens were removed and went into the abdomen and inside the port site incision, with concerns of infection risk to patient.Was the hole in the stomach noted immediately after energy application, during the removal of the remnant stomach, or after the removal of the remnant stomach? she checked the stomach after energy application and noticed that the tissue was ¿blanched¿ more than she normally would see when using an alternative energy device.She then picked up the specimen after stapling and inspected the side where energy had been applied and noticed the tissue separating and completely coming apart upon removal of the specimen, spilling the contents into the abdomen and incision site.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: did the contents spill into the abdomen in 1 case, 2 cases, or all 3 cases? did the surgeon's surgical technique change between each of the patient cases? what was the proximate distance from remnant stomach? what structures was the enseal activating on when the greater than expected thermal spread occurred? approximately how long were the activations? are any surgical photos or videos available for review by engineering and medical? what was done to address the spilt contents? was the patient¿s post op care altered in any way? what is the patient's current status? product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a gastric procedure the surgeon noticed a more than expected thermal spread.The remnant stomach somewhat came apart during removal.She tried moving further away from the edge but this still occurred.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 8/4/2021.Additional information was requested and the following was obtained: did the contents spill into the abdomen in 1 case, 2 cases, or all 3 cases? yes all three cases.Did the surgeon's surgical technique change between each of the patient cases? no, her technique for all three primary sleeves was the same.What was the proximate distance from remnant stomach? she activated around 3-4 mm away from the greater curvature.What structures was the enseal activating on when the greater than expected thermal spread occurred? the greater curvature of the stomach.Approximately how long were the activations? 4 seconds or so, completing the cycle each time.Are any surgical photos or videos available for review by engineering and medical? no photos were taken.What was done to address the spilt contents? an irrigation set was used to wash out the abdominal cavity.Was the patient¿s post op care altered in any way? no.

• 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: 11831678
• MDR Text Key: 250832931
• Report Number: 3005075853-2021-02733
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• 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: 08/02/2021
• Patient Sequence Number: 1
• Treatment: GENERATOR; GENERATOR
• Patient Outcome(s): Required Intervention