HARMONIC WAVE WAVE18SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705036003366), received between Dec 3, 2019 and Dec 3, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem

  TITLE: CLAMP-CRUSH TECHNIQUE VERSUS HARMONIC SCALPEL FOR HEPATIC PARENCHYMAL TRANSECTION IN LIVING DONOR HEPATECTOMY: A RANDOMIZED CONTROLLED TRIAL. AUTHOR : AHMAD MOHAMED SULTAN & AHMED SHEHTA & TAREK SALAH & MOHAMED ELSHOUBARY & AHMED NABIEH ELGHAWALBY, RAMI SAID, MOHAMED ELMORSHEDI & AHMED MARWAN & USAMA SHIHA & OMAR FATHY & MOHAMED ABDEL WAHAB. CITATION: JOURNAL OF GASTROINTESTINAL SURGERY (2019) 23:1568¿1577; DOI: HTTPS://DOI.ORG/10.1007/S11605-019-04103-5. THE AIM OF THIS PROSPECTIVE RANDOMIZED STUDY WAS TO COMPARE THE SAFETY, EFFICACY, AND OUTCOME OF CLAMP-CRUSH TECHNIQUE (KELLY-KLASIA) VERSUS HARMONIC SCALPEL AS A METHOD OF HEPATIC PARENCHYMAL TRANSECTION IN LIVING-DONOR HEPATECTOMY. FROM MA72015 TO APR2016, 72 PATIENTS UNDERWENT RIGHT HEMIPATECTOMY FOR ADULT LIVER DONOR LIVER TRANSPLANTATION (LDLT) AND WERE RANDOMIZED INTO TWO TECHNIQUES OF HEPATIC PARENCHYMAL TRANSECTION: GROUP A ¿ HARMONIC SCALPEL (N=36; N=19 MALE AND N=17 FEMALE; MEAN AGE OF 23.5 YEARS [19-63 YEARS]; BMI OF 26.3 KG/M^2 [18-32.4 KG/M^2), AND GROUP B ¿ SPRAY CLAMP-CRUSH (KELLY-KLASIA)(N=36; N=24 MALE AND N-12 FEMALE; MEAN AGE OF 26 YEARS [18-41 YEARS]; BMI OF 26.2 KG/M^2 [19.7-26.8 KG/M^2]). IN GROUP A, H

  Patient problems: Blood Loss; Necrosis; No Code Available

  MAUDE report 9403663 ↗