MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number EPS03

Device Problem Insufficient Information (3190)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information requested but unavailable: does the surgeon believe that any of the negative patient outcomes are related to an alleged deficiency of ethicon device?.

Event Description

It was reported via the journal article; title: total laparoscopic hysterectomy in 1253 patients using an early ureteral identification technique authors: eiji kobayashi, toko nagase, kazuko fujiwara, tomonori hada, yoshiaki ota, yoshihiro takaki, hiroyuki kanao and masaaki andou citation: j.Obstet.Gynaecol.Res.2012 september;38(9):1194¿1200.Doi:10.1111/j.1447-0756.2012.01849.X the aim of this study was to determine the incidence of perioperative complications and the risk factors for major complications of total laparoscopic hysterectomy (tlh) using an early ureteral identification technique in the absence of any patient exclusion criteria on the basis of substantial experience.A retrospective analysis of patients who underwent total laparoscopic hysterectomy from january 1, 2005 to april 1, 2009 was conducted.Data from 1253 patients (mean age 46.3+/-6.64 years; mean bmi 23+/-3.35 kg/m2) were included in the study.The surgery involved routine use of the suction irrigator probe with a built-in integrated monopolar electrode (endopath probe plus ii).2-0 vicryl was used to ligate the uterine artery at its origin and also to ligate the cardinal ligament above the ureter.After the uterus is delivered, the vaginal vault is closed laparoscopically by intracorporeal suturing with 0-vicryl, where both sides of the vaginal cuff are sutured with z-plasty and continuous sutures are used on the inside.Complications include: bladder injury (n=6; repaired laparoscopically during the same procedure), vaginal dehiscence (n=5; repaired transvaginally), postoperative hydronephrosis [n=5; necessitated reoperation: ureteroneocystostomy (n=3), periureteral adhesiolysis (n=2)], ureteral injury [n=4; repaired laparoscopically during the same procedure: end-to-end anastomosis (n=3), ureteroneocystostomy (n=1)], bowel injury (n=1; repaired laparoscopically during the same procedure by laparoscopic functional end-to-end anastomosis), postoperative hemorrhage (n=1), bowel obstruction (n=1), ureterovaginal fistula (n=1; conservative treatment by inserting a ureteral stent).

• Brand Name: ENDOPATH
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 7038355
• MDR Text Key: 92286517
• Report Number: 3005075853-2017-06163
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K912492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EPS03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention