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 Abscess (1690); Edema (1820); Fistula (1862); Blood Loss (2597)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Date of event: publication year of 2014.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.(b)(4).

Event Description

Title : subtotal supracricoid laryngectomy: changing in indications, surgical techniques and use of new surgical devices.Author: giuditta mannelli a,¿, giuseppe meccariello a, alberto deganello a, francesca romana fiorini a, fabiola paiar b, oreste gallo.Citation: american journal of otolaryngology - head and neck medicine and surgery (2014); 35: 719 ¿ 726.Doi: http://dx.Doi.Org/10.1016/j.Amjoto.2014.07.010.The aim of this study is to evaluate the evolution of supracricoid partial laryngectomy (scpl) in indications, surgical techniques and outcomes through last decades.This retrospective analysis involves 129 patients affected by laryngeal cancer which was treated with scpl between 1995 and 2010.The patients were divided into two different groups: in group a, 90 patients (82 male and 8 female; mean age: 57.4 years ± 9.1 years; age range: 24¿70 years) underwent tumor excision by traditional cold instruments between 1995 and 2004 and in group b, 39 patients (39 male; mean age: 61.2 years ± 7.2; age range: 45-75 years) were treated by using harmonic scalpel (ethicon) between 2005 and 2010.Reported complications in group b included edema of one or both spared arytenoid unit (n-15), pharyngo-cutaneou fistula (n-1), neck abscess (n-2) and postoperative bleeding (n-3).This study documented changing in indications and surgical technique for scpl because of the development of modern diagnostic techniques and the introduction of low-thermal injury device allowing more challenging tumor excision as well as with a shorter swallowing recovery.

• 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: 9383287
• MDR Text Key: 169460403
• Report Number: 3005075853-2019-23802
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/27/2019
• 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
• Patient Outcome(s): Required Intervention