MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

Catalog Number LCSXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Nerve Damage (1979); Seroma (2069); Insufficient Information (4580)

Event Date 12/14/2021

Event Type  Injury  

Event Description

Title: parathyroid hormone level after total thyroidectomy using conventional versus harmonic focus technique: prospective randomized study.Authors: hany abdelfatah elhady *, rasha abd elaziz abd elghany, mohammed shehata zarad.Citation: annals of medicine and surgery (2022); 73:103176.Https://doi.Org/10.1016/j.Amsu.2021.103176.The aim of this prospective randomized study is to compare the effect of using harmonic scalpel and conventional methods during total thyroidectomy on parathyroid hormone level.A total of 100 patients who underwent total thyroidectomy from april 2019 to april 2021 were included.Patients were randomly allocated into two equal groups: group i (n=50; 8 male and 42 female; mean age of 38.06 ± 10.79 years) underwent total thyroidectomy using a harmonic scalpel (hs) during devascularization of thyroid gland and group ii (n=50; 8 male and 42 female; mean age of 33.98 ± 7.07 years) underwent total thyroidectomy using conventional technique by individual ligation of thyroid vessels.Reported complications include temporary hypocalcemia (n=4) which were managed by calcium supplementation and they returned to normal serum ca level within the first two weeks, parathyroid hormone level delined (n=?), external laryngeal nerve injury (n=4), heamatoma (n=1), recurrent laryngeal nerve injury (n=4), and seroma (n=1).In conclusion, the postoperative serum level of parathyroid hormone declined significantly after thyroidectomy if the conventional method was used.Using hs during thyroidectomy is safe and effective with low rates of hypoparathyroidism.

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.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: HARMONIC SCALPEL CURVED SHEAR
• 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: 15402257
• MDR Text Key: 299691463
• Report Number: 3005075853-2022-05960
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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
• Date Manufacturer Received: 08/16/2022
• 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
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention