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 Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2002.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: tonsillectomy using harmonic scalpel.Author/s: n.N.Dutta1, b.M.Bordoloi.Citation: indian journal of otolaryngology and head and neck surgery vol.54 no.I.January - march 2002.The purpose of this study was to review the time taken for surgery, intra-operative and postoperative bleeding, postoperative pain and postoperative complaints after using harmonic scalpel for tonsillectomy.Between aug 2000 to aug 2001, a total of 40 patients [n=19 male, n-21 female, mean age 24.6 years (range 3-73 years)] underwent elective tonsillectomy.Tonsillectomy was performed using harmonic scalpel system (ethicon) in all the cases.Postoperative complications included gross oedema of the uvula and soft palate (with complaint of foreign body sensation in throat and found difficulty in swallowing) (n=27); minimal oedema of the uvula (n=13); and eschar formation (n=?).Our study demonstrates that tonsillectomy using a harmonic scalpel is a good method where dissection time is less, and the method is effective in controlling intra-operative bleeding.It also does not increase the risk of reactionary or secondary haemorrhage and there is less post-operative pain.But, this method is associated with extensive escher formation and oedema of the uvula.

• 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: 9454504
• MDR Text Key: 170862936
• Report Number: 3005075853-2019-24195
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/13/2019

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: 11/13/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other