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

Catalog Number ACEXXX

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

Patient Problems Fistula (1862); Sepsis (2067); Blood Loss (2597)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/26/2019.Date of event: publication year of 2011.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: use of the new ultrasonically curved shear in pancreaticoduodenectomy for periampullary cancer.Authors: sohei satoi; hiroaki yanagimoto; hideyoshi toyokawa.Citation: j hepatobiliary pancreat sci (2011) 18:609¿614; doi 10.1007/s00534-011-0370-0.The aimed of this prospective study was to examine whether the use of the new ultrasonically curved shear (ucs) can reduce the number of surgical stitches, extent blood loss, and operation time in (pylorus-preserving) pancreaticoduodenectomy (pd) for periampullary cancer.From september 2009 to april 2010, 26 patients with periampullary cancer underwent pd, including pppd.The patients were divided into two groups: group a consisted of 13 consecutive cancer patients (male=10, female=3; mean age=64 years, age range=50-81 years) who underwent conventional pd.Group b consisted of 13 patients (male=8, female=5; mean age=72 years, age range=38-86 years) using the ucs for dissection.Ucs ¿ harmonic focus (ethicon) was used in the procedure.Reported complications included mean blood loss of 790 ml (range 239-1664 ml) (n=13) in which transfusion was performed to 7 patients; septic complications (n=2); and pancreatic fistula (n=5).In conclusion, the use of the new ucs in pd was safe procedure and associated with the economical benefit of fewer surgical stitches as well as with reduced blood loss and reduced operative time spent during the hilar part of pd.

• Brand Name: ULTRACISION HARMONIC ACE (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: 9520006
• MDR Text Key: 189024082
• Report Number: 3005075853-2019-24749
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K051036
• 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: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1