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 Problem Insufficient Information (4580)

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: modified endoscopic denker¿s approach for management of anterior maxillary sinus tumors: multicenter series of 58 cases.Author: justin p.Mccormick, md , jeffrey d.Suh, md, eric w.Wang, md , adam s.Deconde, md, marilene b.Wang, md , hong-ho yang, bs , taylor r.Carle, md, vivian wung, md, jivianne t.Lee, md.Citation cite : american journal of rhinology & allergy 2022, vol.36(6) 763¿772 doi: 10.1177/19458924221110652.A multi-institutional retrospective review of patients undergoing the med approach for resection of tumors involving the anterior maxillary sinus was performed from 2009 to 2020.The med approach was performed, as has been previously described.A total of 58 patients were identified.An endoscopic medial maxillectomy is performed.Electrocautery with a guarded needle tip (megadyne) is used to make a mucosal incision at the junction of the nasal floor and lateral nasal wall through the periosteum.Reported complications included 82 male patient experienced severe epistaxis and upper lip numbnessa 62 years old female patient experienced epiphora requiring dcr, 58 years old female experienced facial numbness, 68 years old female experienced epiphora, 29 years old male experienced epiphora requiring dcr, 37 years old male patient experienced scarring/granulation tissue at site of dcr with subsequent epiphora.In conclusion the modified endoscopic denker¿s approach is highly effective for surgically accessing tumors of the anterior maxillary sinus.The procedure can be performed safely with a low risk of complications, the most common of which include epiphora and facial numbness.Although this approach has been used primarily for inverted papillomas, it shows promise in the treatment of other neoplasms of this region.

• 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: 15707659
• MDR Text Key: 302775214
• Report Number: 1721194-2022-00101
• 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