MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM; STAPLE, IMPLANTABLE

Catalog Number EC60A

Device Problem Insufficient Information (3190)

Patient Problems Failure to Anastomose (1028); No Code Available (3191)

Event Date 12/21/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Date sent: 1/20/2016.Information asked for but unknown or not provided during initial contact.Information not available, device not returned for analysis should the information be provided later, a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot/batch.Additional information requested and received: what were the indications for surgery? the diagnosis (since (b)(6) 2015) cancer of ascending colon, stage iia, related: chronic hypochromic anemia of the mixed genesis of moderate severity.Miocardiodistrofia timetables.Circulatory insufficiency of 1st degree.Polycystic kidney disease.Were any issues noted with stapler performance or staple formation in primary procedure? no.Was the patient on steroids, chemo or radiation therapy? no.What color cartridges were used throughout procedure and where were they used? ecr60d, gold were any other stapling devices or suture used to complete the anastomosis in primary procedure? no was the site of the leak in the common channel or top of anastomosis? after the main procedure during laparotomy revealed the failure of the stump of the colon in the area of stapling, with pressure on the area of the anastomosis revealed an abundant flow of intestinal contents through stapling line of the stumps of the colon and the small intestine.It was decided to perform resection of the anastomosis, to make a new ileotransversostoma and to drain the abdominal cavity.The resection of ileotransversostoma was made with linear cutter 100, the stumps of the colon and small intestine were strengthened with a third row of separate interrupted stitches with monolithic thread.An isoperistaltic ileotransversostoma was created by double-row separate interrupted stitches with monolithic thread.What is the current patient status? unfortunately, the patient died.After the death the main diagnosis was established: cancer of the ascending colon, state after laparoscopic hemicolectomy with right hand extended lymphadenectomy (b)(6) 2015¿ the complications of the main diagnosis: insolvency of ileotransverzoanastomoza, secondary diffuse peritonitis seroplastic, condition after laparotomy, ileotransverzoanastomoza resection, re-imposing of ileotransverzoanastomoza, drainage of the abdominal cavity (b)(6) 2015, relaparotomy, sanitation, drainage of the abdominal cavity (b)(6) 2015 lobar pneumonia left severe, bilateral pleural effusion septic shock¿.And comorbid diagnoses cardiac ischemia atherosclerotic cardiosclerosis.Myocardial dysmetabolic.Chronic hypochromic anemia of mixed genesis of moderate severity.Multicystic kidney disease¿.

Event Description

It was reported that after a laparoscopic right hemicolectomy with extended d3 lymphadenectomy procedure, during the performed operation the device and three reloads were used to create the anastomosis (antiperistaltics side-to-side ileotransversostoma).There were no technical issues and complications during the procedure.However, thirty hours later after the operation was finished, the patient's condition deteriorated: appeared hemodynamic disturbances, shortness of breath, abdominal pain and lack of intestinal motility.According to the general blood analysis - leukocytosis, a sharp rise in the number of leukocytes stab.Given the emergence of the clinical data of failure of the anastomosis a council of doctors was convened and the decision to perform emergency relaparoscopy was made.The resection of ileotransversostoma was made with linear cutter 100, the stumps of the colon and small intestine were strengthened with a third row of separate interrupted stitches with monolithic thread.An isoperistaltic ileotransversostoma was created by double-row separate interrupted stitches with monolith thread.Intensive treatment was performed in the icu.The patient is currently stable.

Manufacturer Narrative

(b)(4).Date sent: 2/18/2016.Additional information requested and received: was the ec60a device used for the first time or was it reprocessed and used on another patient? ec60a device was used for the first time.Was the cause of death confirmed? yes.Was an autopsy done and is the report available? unfortunately, the report isn¿t available, the hospital can¿t give us this information.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5379291
• MDR Text Key: 36393637
• Report Number: 3005075853-2016-00425
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K081146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2018
• Device Catalogue Number: EC60A
• Device Lot Number: M91828
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR