MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. UNK_ULTRACISION HARMONIC FOCUS; SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HANDPIECE TIP, SINGLE-USE

Catalog Number UNK_ULTRACISION HARMONIC FOCUS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Wound Dehiscence (1154)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Title: a novel technique using ultrasonic shears versus traditional methods of reduction of bilateral labia minora hypertrophy: a retrospective case-control study authors: maj, thuan h.Le, usaf, mc; col(r), ernest g.Lockrow, mc, usa; maj, scott p.Endicott, mc, usamaj, thuan h.Le, usaf, mc; col(r), ernest g.Lockrow, mc, usa; maj, scott p.Endicott, mc, usa.Citation: military medicine, vol.00, month/month 2022.This paper intends to evaluate the surgical outcomes of using ultrasonic technology, the harmonic focus+ shears, in labial hypertrophy reduction in comparison to other traditional methods.In this retrospective study, we evaluate the surgical outcomes of 11 women who underwent bilateral labia minora hypertrophy reduction using ultrasonic shears to 14 women who underwent the same procedure using various traditional methods between january 1, 2015 and february 29, 2020.Implants used for the ultransonic shears was the harmonic focus+shears (ethicon, cincinnati, ohio).A 5 mm separation of the tissue edges occurred in one case on postoperative day four which required a single interrupted suture repair.Ultrasonic shears significantly reduce the time needed for the reduction of bilateral labia minora hypertrophy and therefore should be considered by surgeons as a useful tool in increasing the efficiency of this procedure.

Manufacturer Narrative

(b)(4).Date of event: publication year of 2022.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK_ULTRACISION HARMONIC FOCUS
• Type of Device: SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HANDPIECE TIP, SINGLE-USE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15455348
• MDR Text Key: 300260338
• Report Number: 3005075853-2022-06250
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ULTRACISION HARMONIC FOCUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention