MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. UNK_E-Z CLEAN NON-STICK ELECTROSURGICAL ELECTRODES; E-Z CLEAN BAYONET NEEDLE 6 INCH

Catalog Number UNK_E-Z CLEAN NON-STICK ELECTR

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Discomfort (2330); Numbness (2415)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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.

Event Description

Title: the cleft lift procedure for pilonidal disease renamed as a rotation and advancement flap procedure (raf): insights and technical tips for a successful outcome.Author: jeffrey a.Sternberg, md.Citation cite : seminars in colon and rectal surgery 000 (2022) 100913.Https://doi.Org/10.1016/j.Scrs.2022.100913.This technical paper deconstructs the confusing terminology, suggests simple steps for success, and proposes a more descriptive name for the asymmetric flap procedure which has the lowest reported recurrences for all surgical options for pilonidal disease.The author has successfully performed the cleft lift procedure for pilonidal disease since 2000.In the last consecutive 757 patients treated over 12 years.Using a knife or electrocautery on a clean pure cutting mode (ace by megadyn).Reported complication included minimal postoperative discomfort and actually experience numbness on the flap side of the incision for 6 to 8 weeks.6 patients required a second operation due to recurrence.In conclusion the pilonidal raf procedure is highly successful in treating pilonidal sinus disease with a very low need for additional surgery even in complex recurrent disease.

• Brand Name: UNK_E-Z CLEAN NON-STICK ELECTROSURGICAL ELECTRODES
• Type of Device: E-Z CLEAN BAYONET NEEDLE 6 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15708493
• MDR Text Key: 302781030
• Report Number: 1721194-2022-00105
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081791
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_E-Z CLEAN NON-STICK ELECTR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention