MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number LCSXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Obstruction/Occlusion (2422); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2013.Batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.

Event Description

Title:laparoscopic excision of a choledochal cyst in 82 consecutive patients.Authors: jin-young jang ¿ yoo-seok yoon ¿ mee joo kang ¿ wooil kwon ¿ jae woo park ¿ ye rim chang ¿ young-joon ahn ¿ jai young cho ¿ ho-seong han ¿ sun-whe kim.Citation: surg endosc (2013) 27:1648¿1652; doi 10.1007/s00464-012-2646-0.The purpose of this study was to evaluate the long-term results of the laparoscopic excision of choledochal cyst and to review pitfalls and important points during this procedure.Between 2003 and 2011, 77 patients with choledochal cyst underwent excision using four-hole method.In the procedure, the choledochal cyst was dissected by using harmonic scalpel (ethicon, nj, usa) and bipolar bovies to ensure the hemostasis of epicholedochal venous plexus.After the excision of the choledochal cyst, they made a roux-en-y hepaticojejunostomy retrocolically.Postoperative complications included bile leakage (n=5), intraabdominal fluid collection (n=3); bleeding (n=1), bleeding at the mesenteric length site of roux-en-y on day 1 (n=1) which was treated with laparoscopic suturing; pancreatic fistula (n=1); and intestinal obstruction (n=1) managed by open laparotomy.Other patients recovered after conservative treatment.Pancreatic duct injury and immediate obstruction of hj resulted from excessive dissection and resection for the complete removal of the choledochal cyst to the level of the pancreatic duct and hepatic hilum.In the hj obstruction case, resection of the choledochal cyst was performed up to the level of the left and right hepatic duct for the type iva case, and it took a long time to complete the hj in the hepatic ducts small diameters (3¿4 mm).The other complication was bleeding at the site of mesenteric lengthening; in the past, they used an ultrasonic scalpel to lengthen the mesentery to make the rouxen-y loop.Laparoscopic management can be a treatment of choice for the most instances of choledochal cyst considering its good cosmetic results and its feasible level of operative safety.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9470648
• MDR Text Key: 174873277
• Report Number: 3005075853-2019-24346
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention