UNK_HARMONIC HD1000I
Report
- Report Number
- 3005075853-2025-04904
- Event Type
- Injury
- Date Received
- June 30, 2025
- Date of Event
- June 29, 2023
- Report Date
- June 30, 2025
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
(B)(4). DATE SENT: 6/30/2025. B3: PUBLICATION YEAR OF 2023. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 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.
IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: COMPARISON OF MEDISONIC WITH HARMONIC HD 1000I AND SONICISION ULTRASONIC ENERGY DEVICE IN LAPAROSCOPIC GASTRECTOMY: A PILOT RANDOMIZED CLINICAL TRIAL. AUTHORS: SO JUNG KIM, AHMAD GADAH, KYO YOUNG SONG. CITATION: SO JUNG KIM, ET AL: COMPARING MEDISONIC WITH OTHER ULTRASONIC ENERGY DEVICES ANNALS OF SURGICAL TREATMENT AND RESEARCH 2023: 105 (2) :91-98. HTTPS://DOI.ORG/10.4L74/ASTR.2023.105.2.91. THIS STUDY AIMED TO COMPARE THE CLINICAL PERFORMANCE OF MEDISONIC (DAIWHA CORP.) TO THAT OF HARMONIC HD 1000I (ETHICON ENDO-SURGERY) AND SONICISION (MEDTRONIC) IN PATIENTS UNDERGOING GASTRECTOMY FOR GASTRIC CANCER. BETWEEN JULY AND DECEMBER 2021, A TOTAL OF 30 PATIENTS (18 MALE AND 12 FEMALE) WITH A MEAN AGE OF 58.8 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS UNDERWENT LAPAROSCOPIC RADICAL DISTAL GASTRECTOMY, AND WAS DIVIDED INTO 3 ULTRASONIC ENERGY DEVICE GROUPS. THE HARMONIC GROUP (N=10) USING HARMONIC HD 1000I (ETHICON ENDO-SURGERY), THE SONICISION GROUP (N=10) USING SONICISION (MEDTRONIC), AND THE MEDISONIC GROUP (N=10) USING MEDISONIC (DAIWHA CORP.). PATIENT CHARACTERISTICS, OPERATIVE DATA, PERIOPERATIVE OUTCOMES, AND POSTOPERATIVE COMPLICATIONS WERE OBSERVED AND COMPARED. REPORTED COMPLICATIONS FOR THE HARMONIC GROUP INCLUDE (N=1) INTRAABDOMINAL ABSCESS, (N=1) DELAYED GASTRIC EMPTYING, AND (N=1)DUODENAL STUMP LEAKAGE. CONCLUSION: MEDISONIC IS SAFE AND EFFICIENT TO PERFORM LAPAROSCOPIC RADICAL GASTRECTOMY AND IS NOT INFERIOR TO HARMONIC HD 1 000I OR SONICISION IN TERMS OF CLINICAL OUTCOMES AND CUTTING/SEALING FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2290509 | UNK_HARMONIC HD1000I | UNK_HARMONIC HD1000I | LFL | ETHICON ENDO-SURGERY, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | GENERATOR |