Harmonic LaparoSonic HDH05Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705036002109), received between Nov 20, 2017 and May 4, 2026 — classified as 9 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC MYOMECTOMY, THE FIBROID WAS TOO LARGE TO REMOVE, SO WHILE THE HDH05 WAS USED TO DIVIDE IT, THE BLADE SUDDENLY BROKE. THERE WERE NO UNUSUAL SOUNDS SUCH AS METALLIC SOUNDS AT ALL. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073533 ↗
• MalfunctionMar 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN OB-GYN SURGERY, THE TIP WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643050 ↗
• MalfunctionFeb 13, 2026Material Separation

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC MYOMECTOMY, THE TIP OF THE BLADE WAS BROKEN WHEN TRIED TO GRAB THE FIBROID IN A NORMAL WAY. THE BLADE WAS RETRIEVED WITHOUT ANY PROBLEMS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332372 ↗
• MalfunctionJul 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, AFTER OPENING THE DEVICE AND THE DEVICE WAS ACTIVATED, THE BLADE BROKE SUDDENLY. THE BROKEN PART WAS ALL COLLECTED. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554552 ↗
• MalfunctionAug 22, 2024Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC MYOMECTOMY, ¿TIGHTEN ASSEMBLY ¿WAS DISPLAYED AND IT WAS FOUND THAT THE BLADE WAS BROKEN. THE DEVICE WAS USED AS USUAL, AND THE TISSUE WAS NO DIFFERENT FROM USUAL. THE DEVICE WAS USED ON UTERUS. NO PIECES WERE LEFT INSIDE THE PATIENT. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039511 ↗
• MalfunctionMay 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PRODUCT, WHEN CONNECTED TO THE GENERATOR, HAD THE FOLLOWING PROBLEM: RUPTURE OF THE LAPAROSCOPIC TERMINAL HOOK, DURING ITS ACTIVATION, AT THE UTERINE MYOMA, DURING THE INTRA-ABDOMINAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19386695 ↗
• MalfunctionApr 5, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC CARDIOVASCULAR SURGERY, THE ROOT PART OF THE DEVICE HAD HEAT EXCESSIVELY AND WAS MELTED. THE DEVICE WAS USED AS USUAL. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049913 ↗
• MalfunctionOct 9, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP STOPPED WORKING. NO CONSEQUENCES FOR THE PATIENT REPORTED. TO PROCEDURE COMPLETED PHYSICIAN USED ANOTHER ONE PRODUCT THE SAME TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894365 ↗
• MalfunctionAug 3, 2023Material Separation; Failure to Disconnect; Material Separation; Failure to Disconnect

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE GLUED PART CAME OFF WHEN THE HOOK PART WAS HOOKED ON THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452700 ↗
• MalfunctionJun 2, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE AN UNKNOWN PROCEDURE, THERE WAS A HOLE ON THE PACKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050343 ↗
• MalfunctionMar 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC MYOMECTOMY, IT WAS FOUND THAT THE PIN CAME OFF. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16505287 ↗
• InjuryOct 4, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  TITLE: MINIMALLY INVASIVE CORONARY ARTERY BYPASS GRAFTING WITH ULTRASONICALLY SKELETONIZED INTERNAL THORACIC ARTERY. AUTHOR: KAZUTOSHI TACHIBANA, MD, PHD,A KEITA KIKUCHI, MD, PHD,B KOUHEI NARAYAMA, MD,B AKIHITO OKAWA, MD,A YU IWASHIRO, MD,A AYAKA ARIHARA, MD,A AND AKIHIKO YAMAUCHI, MD, PHDB. CITATION: JTCVS TECHNIQUES C VOLUME 14, NUMBER C HTTPS://DOI.ORG/10.1016/J.XJTC.2022.05.010. THIS STUDY AIMS TO EXAMINED THE AUTHORS¿ INITIAL EXPERIENCE OF CONSECUTIVE CASES WITH MINIMALLY INVASIVE CARDIAC SURGERY CORONARY ARTERY BYPASS GRAFTING (MICS CABG) USING ULTRASONICALLY SKELETONIZED INTERNAL THORACIC ARTERY (ITA). FROM FEBRUARY 2012 TO MAY 2021, 247 PATIENTS (194 MALES AND 53 FEMALES) AGE 65.9 -11.5 YEAR UNDERWENT WITH MINIMALLY INVASIVE CARDIAC SURGERY CORONARY ARTERY BYPASS GRAFTING (MICS CABG) AS PERFORMED BY 3 SURGEONS (K.K., A.Y., AND K.T.) AT MULTIPLE INSTITUTES. THE LEFT INTERNAL THORACIC ARTERY (LITA) AND RIGHT INTERNAL THORACIC ARTERY (RITA) WERE HARVESTED IN A FULL SKELETONIZED FASHION UNDER DIRECT VISION THROUGH AN 8- TO 10-CM LEFT MINITHORACOTOMY INCISION, AND OFF-PUMP MICS CABG (OPCAB) WAS DONE BASICALLY. DURING HARVESTING, THE RIGHT INTERNAL THORACIC ARTERY (RITA) WAS HARV

  Patient problems: Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pleural Effusion

  MAUDE report 15540022 ↗
• MalfunctionOct 3, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY THE HOOK ON THE END OF THE DEVICE BROKE IN HALF. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528146 ↗
• MalfunctionAug 30, 2022Material Separation; Noise, Audible; Material Separation; Noise, Audible

  IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, AN UNEXPECTED METALLIC SOUND WAS HEARD. THE BLADE WAS BROKEN. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321388 ↗
• MalfunctionApr 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE LAP SUPRACERVICAL HYSTERECTOMY, WHEN THE SURGEON WAS CUTTING THE CERVIX WITH THE BLADE, THE TIP OF THE DEVICE BROKE OFF. THE FRAGMENTS WERE RETRIEVED. A LIKE DEVICES WAS USED TO COMPLETED THE PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187773 ↗
• MalfunctionMar 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE THAT WHILE DOING THE CULPOTOMY A RUMI WAS INSERTED INTO THE VAGINA WHEN THE BLADE TIP FELL OFF INTO THE PATIENT. TIP WAS ATTEMPTED TO BE REMOVED WITH AN ENSEAL DEVICE TO REMOVE THROUGH THE TROCAR BUT WHEN INSPECTED THEY DID NOT SEE THE TIP IN THE JAWS OF THE ENSEAL. THEY PROCEEDED WITH AN X-RAY TO LOCATE THE TIP. THE TIP WAS NOT LOCATED WITH THE X-RAY. THEY THEN INSPECTED THE TROCAR AND FOUND THE TIP IN THE TROCAR HOUSING. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803111 ↗
• MalfunctionFeb 16, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE HOOK BROKE OFF WHILE THE DOCTOR WAS USING. CASE COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545840 ↗
• MalfunctionDec 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN OB-GYN PROCEDURE THE DEVICE¿S BLADE BROKE DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019834 ↗
• MalfunctionSep 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, BLADE BROKE DURING USE. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12521427 ↗
• MalfunctionAug 30, 2021Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE BLADE BROKE. NO PIECE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388634 ↗
• MalfunctionAug 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE BLADE BROKE . NO PIECE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388623 ↗
• MalfunctionMay 13, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY, THE DEVICE WOULD NOT ACTIVATE AND COAGULATE DURING USE. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10051878 ↗
• MalfunctionFeb 24, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY, THE DEVICE BECAME NOT TO COAGULATE THE TARGET TISSUE ABOUT 30 MINUTES AFTER THE OPERATION STARTED. WHEN THE DEVICE WAS REMOVED FROM THE HP WITH THE TORQUE WRENCH, THE TIP OF THE BLADE WAS BROKEN OFF. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745948 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem

  TITLE : LAPAROSCOPIC MITROFANOFF PROCEDURE IN CHILDREN: CRITICAL ANALYSIS OF DIFFICULTIES AND BENEFITS. AUTHOR : THOMAS BLANC, CECILE MULLER, MAGUELONNE PONS, POURYA PASHOOTAN, ANNABEL PAYE-JAOUEN, ALAA EL GHONEIMI. CITATION: JOURNAL OF PEDIATRIC UROLOGY (2015) 11, 28.E1-28.E8; DOI: HTTP://DX.DOI.ORG/10.1016/J.JPUROL.2014.07.013. THIS RETROSPECTIVE STUDY DISCUSSED ABOUT THE FEASIBILITY AND POSSIBLE BENEFITS OF USING A LAPAROSCOPIC APPROACH IN CHILDREN WITH SIGNIFICANT BLADDER DYSFUNCTION ASSOCIATED WITH DIFFICULTY DOING EFFICIENT URETHRAL CATHETERIZATION. BETWEEN 2003 AND 2013, FULLY LAPAROSCOPIC MITROFANOFF (LMA) WAS ATTEMPTED IN 15 CHILDREN (MALE=12, FEMALE=3; MEAN AGE=9 YEARS). DURING THE PROCEDURE, A CAUDAL SUTURE BETWEEN THE APPENDIX AND THE BLADDER MUCOSA WAS INCLUDED THE DETRUSOR MUSCLE TO FIX THE CAUDAL PART OF THE ANASTOMOSIS AND STABILIZE THE ANASTOMOTIC LINE DURING SUTURING. AFTER COMPLETING THE ANASTOMOSIS, THE APPENDIX WAS PLACED IN THE NEWLY PREPARED DETRUSOR MUSCLE TROUGH, AND THE SEROMUSCULAR LAYER OF THE BLADDER WAS CLOSED OVER THE APPENDIX. TO AVOID COMPRESSION OF THE MESENTERY, THE SUTURES WERE DONE THROUGH THE MESENTERY UNDER LAPAROSCOPIC VISION, USING INTERRUPT

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 9612804 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem

  TITLE : LAPAROSCOPIC MITROFANOFF PROCEDURE IN CHILDREN: CRITICAL ANALYSIS OF DIFFICULTIES AND BENEFITS AUTHOR : THOMAS BLANC, CECILE MULLER, MAGUELONNE PONS, POURYA PASHOOTAN, ANNABEL PAYE-JAOUEN, ALAA EL GHONEIMI. CITATION: JOURNAL OF PEDIATRIC UROLOGY (2015) 11, 28.E1-28.E8; DOI: HTTP://DX.DOI.ORG/10.1016/J.JPUROL.2014.07.013. THIS RETROSPECTIVE STUDY DISCUSSED ABOUT THE FEASIBILITY AND POSSIBLE BENEFITS OF USING A LAPAROSCOPIC APPROACH IN CHILDREN WITH SIGNIFICANT BLADDER DYSFUNCTION ASSOCIATED WITH DIFFICULTY DOING EFFICIENT URETHRAL CATHETERIZATION. BETWEEN 2003 AND 2013, FULLY LAPAROSCOPIC MITROFANOFF (LMA) WAS ATTEMPTED IN 15 CHILDREN (MALE=12, FEMALE=3; MEAN AGE=9 YEARS). DURING THE PROCEDURE, A CAUDAL SUTURE BETWEEN THE APPENDIX AND THE BLADDER MUCOSA WAS INCLUDED THE DETRUSOR MUSCLE TO FIX THE CAUDAL PART OF THE ANASTOMOSIS AND STABILIZE THE ANASTOMOTIC LINE DURING SUTURING. AFTER COMPLETING THE ANASTOMOSIS, THE APPENDIX WAS PLACED IN THE NEWLY PREPARED DETRUSOR MUSCLE TROUGH, AND THE SEROMUSCULAR LAYER OF THE BLADDER WAS CLOSED OVER THE APPENDIX. TO AVOID COMPRESSION OF THE MESENTERY, THE SUTURES WERE DONE THROUGH THE MESENTERY UNDER LAPAROSCOPIC VISION, USING INTERRUPTE

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 9612788 ↗