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 Fever (1858); Flatus (1865); Pain (1994); Urinary Retention (2119); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

Title: double-blind, randomized trial comparing harmonic scalpel¿ hemorrhoidectomy, bipolar scissors hemorrhoidectomy, and scissors excision ligation technique.Author/s: c.C.Chung, f.R.C.S.E., j.P.Y.Ha, f.R.C.S.E., y.P.Tai, f.R.S.C.E., w.W.C.Tsang, f.R.C.S.E, m.K.W.Li, f.R.C.S.(eng.), f.R.C.S.E.Citation: dis colon rectum (2002); 45:789¿794.The aim of this study was to compare the outcome of patients receiving hemorrhoidectomy using harmonic scalpel, bipolar scissors, and the conventional scissors excision¿ligation technique.This double-blind randomized trial from april 1999 to january 2001 includes 86 patients with irreducible prolapsing piles.The patients were randomly allocated to one of the following three groups: in mmh group, 27 patients (13 male and 14 female; mean age: 44.7±14.5 years) underwent milligan-morgan hemorrhoidectomy (mmh); in bsh group, 30 patients (16 male and 14 female; mean age: 50.7±12.2 years) underwent bipolar scissors hemorrhoidectomy using powerstar bipolar scissors (ethicon); and in hsh group, 29 patients (13 male and 16 female; mean age: 49±14.9 years) underwent harmonic scalpel hemorrhoidectomy using harmonic scalpel (ultracision 10-mm coagulating shears; ethicon).In the bsh group, the skin incision was made by means of the bipolar scissors without cautery, to avoid burning of the skin bridges.The hemorrhoidal bundle was carefully dissected off the internal sphincter, up to the pedicle at the anorectal ring.The hemorrhoid was then excised.Bleeding, if any, was controlled by the bipolar scissors cautery.The pedicle of each hemorrhoid was grasped and coagulated between the scissors rather than being transfixed.In hsh group, the operation resembled bsh, except that the dissection and hemostasis were purely performed with the harmonic scalpel.Again, the pedicle was controlled by coagulation using the harmonic scalpel.Reported complication in the bsh group included pain/worsened pain (n-?), urinary retention (n-1), fever (n-1), and anal stenosis (n-1), and in the hsh group included pain/worsened pain (n-?), and flatus incontinence (n-1).In conclusion, the study shows that harmonic scalpel hemorrhoidectomy is as good as bipolar scissors hemorrhoidectomy in terms of reduced blood loss but is superior because it is associated with less postoperative pain and hence, better patient satisfaction.

• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 9264066
• MDR Text Key: 181319708
• Report Number: 3005075853-2019-23135
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• 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: 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention