MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS SYNERGY CURVED BLADE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	SNGCB
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Impaired Healing (2378)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 7/1/2025.B3: publication year of 2021.D4: batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.This report is being submitted as part of a retrospective review of published scientific articles captured under capa-014204.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.
Event or Problem Description
Title: a comparative study of cold dissection tonsillectomy and harmonic scalpel tonsillectomy under microscope - our experience authors: sunil kumar samdani, jugal kishore, vipasha yogi, sanjay sharma, amreen.Citation cite: (december 2022) 74(suppl 3):s5395¿s5403; https://doi.Org/10.1007/s12070-021-02586-w.The aim of this prospective comparative study is to compare different variables such as tonsillectomy time, intraoperative blood loss, post operative pain and wound healing with the two methods (harmonic scalpel and cold dissection) under microscopic visualisation to select the best method according to the patient¿s condition.From july 2019 to june 2020, a total of 40 cases with ages between 4¿14 years (mean age of 8 years in which 31 were males and 9 were females) diagnosed as adeno-tonsillar hypertrophy of grade 3-4 were studied.Age and gender distribution has no effect in comparison of outcomes as each patient underwent tonsillectomy by cold dissection method on one side and by ultrasonic scalpel on other and this was decided by odd even method of randomization.Microscope was used for tonsillectomy on either side.In cold dissection method done by eve¿s tonsillar snare.On the side assigned to the harmonic scalpel, tonsillectomy was performed using the hook blade (harmonic scalpel, synergy, ethicon endosurgery, llc guaynabo, puerto rico 00,969 usa).Reported complications include intraoperative blood loss, post operative pain, delayed wound healing.In conclusion, harmonic tonsillectomy had better outcome with respect to operation time, intraoperative blood loss, post-operative pain and post operative haemorrhage when compared to cold dissection tonsillectomy.In view of wound healing, cold dissection tonsillectomy was found to be better than harmonic scalpel tonsillectomy.

• Brand Name: HS SYNERGY CURVED BLADE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• 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 ; * ; 3035526892
• MDR Report Key: 22370845
• Report Number: 3005075853-2025-04926
• Device Sequence Number: 4617486
• Product Code: LFL
• UDI-Device Identifier: 10705036002802
• UDI-Public: 10705036002802
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K012176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: SNGCB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown