N/A (REF HAR36)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00885825017347), received between Oct 25, 2016 and Jul 24, 2018 — classified as 16 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE TEFLON PAD MELTED OFF THE HARMONIC SCALPEL (HAR36) DURING THE LAPAROSCOPIC PROCEDURE. THE TEFLON PAD FELL INTO THE PATIENT AND WAS REMOVED THROUGH ONE OF THE PORTS. THE DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716211 ↗
• MalfunctionJun 12, 2018Break; Break

  IT WAS REPORTED THE HARMONIC SCALPEL (HAR36) TIP BROKE DURING USE. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS SPECIFIC EVENT. HOWEVER, NO OTHER INFORMATION WAS PROVIDED FROM THE FACILITY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7593966 ↗
• MalfunctionMay 15, 2018Device Inoperable; Device Operational Issue; Device Inoperable; Device Operational Issue

  IT WAS REPORTED THE BUTTON ON A HARMONIC SCALPEL DID NOT WORK. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7517117 ↗
• MalfunctionMay 3, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT THE HARMONIC SCALPEL QUIT WORKING DURING CASE. THE FACILITY IS UNKNOWN AND THUS, NO OTHER INFORMATION IS KNOWN. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7485720 ↗
• MalfunctionApr 26, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THE TEFLON PAD FELL OFF THE HARMONIC SCALPEL (HAR36) INTO THE PATIENT AND WAS RETRIEVED BY THE DOCTOR. THE DOCTOR NOTICED IT FALL OFF ON SCREEN. A LARGER INCISION WAS NOT MADE TO RETRIEVE THE PIECE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT 2 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE. THE DEVICE WAS REPLACED AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7465791 ↗
• InjuryApr 16, 2018Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message; Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message

  IT WAS REPORTED THE HARMONIC SCALPEL WAS NOT WORKING PROPERLY AND AN ERROR MESSAGE APPEARED ON THE GENERATOR. THE ERROR MESSAGE IS UNKNOWN BY THE FACILITY. THE GENERATOR WAS RESTARTED AND IT WAS REPORTED "OKAY FOR A WHILE BUT THEN IT WOULD NOT FIRE OCCASIONALLY". THE PHYSICIAN WOULD ATTEMPT TO PRESS THE BUTTON SEVERAL TIMES FOR THE DEVICE TO ACTIVATE BUT IT WOULD ONLY CAUTERIZE FOR A SHORT PERIOD OF TIME. THUS, THE GALL BLADDER WAS NOT TAKEN OFF THE LIVER BED PROPERLY AND IT WAS REPORTED THERE WAS "MORE BLOOD LOSS THAN USUAL BUT NOTHING EXTENSIVE". THE PROCEDURE WAS EXTENDED 20 MINUTES TO CONTROL BLEEDING. THE DEVICE WAS REPLACED WITH A MONOPOLAR SPATULA CAUTERY DEVICE TO CAUTERIZE THE LIVER BED. SURGICAL WAS USED TO CONTROL BLEEDING AND A DRAIN WAS PLACED. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7435335 ↗
• MalfunctionMar 29, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING THE OPERATION, THE TEFLON PAD FELL OFF THE HARMONIC SCALPEL (HAR36). THE FACILITY STATED THE TEFLON PAD DID NOT FALL IN THE PATIENT, TO THEIR KNOWLEDGE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380935 ↗
• MalfunctionMar 5, 2018Mechanics Altered

  THE HAND PIECE ROTATING MECHANISM WAS STIFF AND NOT TWISTING. THE SURGEON WAS UNABLE TO MANIPULATE THE DEVICE TO USE FOR THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 7312820 ↗
• MalfunctionJan 30, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THE HARMONIC SCALPEL (HAR36) BLADE BROKE OFF. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7229707 ↗
• MalfunctionJan 16, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THE HARMONIC SCALPEL (HAR36) TIP BROKE OFF AS THEY WERE GOING TO USE ON PATIENT. THE PATIENT WAS IN THE ROOM, HOWEVER, THE EVENT OCCURRED PRIOR TO USE ON PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THE DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7194779 ↗
• MalfunctionJan 12, 2018Device Operates Differently Than Expected

  IT WAS REPORTED BY SURGICAL STAFF THAT A REPROCESSED HARMONIC DEVICE WAS NOT PROPERLY WORKING. THE DEVICE WAS REMOVED FROM SERVICE AND REPLACED WITH A WORKING DEVICE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO HARM TO THE PATIENT. THE DEVICE WAS GIVEN TO CLINICAL ENGINEERING. UPON PHYSICAL EXAMINATION, THERE WERE NO VISIBLE DEFECTS TO THE DEVICE. IT WILL BE RETURNED TO THE REPROCESSING MANUFACTURER FOR FAILURE ANALYSIS. THE STRYKER SUSTAINABILITY REPRESENTATIVE HAS BEEN NOTIFIED AND WE WILL RETURN THIS DEVICE FOR FAILURE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185439 ↗
• InjuryDec 21, 2017Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message; Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING USE, TWO ERRORS TO RELEASE PRESSURE OCCURRED WITH HARMONIC SCALPEL (HAR36). THE DEVICE WOULD 'BUZZ' WITH TISSUE CONTACT AND ANOTHER ERROR WOULD COME UP TO RELEASE PRESSURE. THE SAME ISSUE OCCURRED WITH SIX DEVICES USED IN THIS CASE. IN TOTAL, 400CC OF BLOOD WAS LOST IN THE LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) AND 200CC WAS LOST IN THE BILATERAL TUBAL LIGATION (BTL). NO TRANSFUSION WAS REQUIRED. A TUBE AND OVARY WERE REMOVED DUE TO BEING UNABLE TO MAKE THE DEVICES WORK PROPERLY. IN TOTAL, THE PROCEDURE WAS DELAYED 30 MINUTES IN THE LAVH AND 20 MINUTES IN THE BTL. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION WAS STABLE POST-PROCEDURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7140734 ↗
• InjuryDec 21, 2017Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message; Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING USE, TWO ERRORS TO RELEASE PRESSURE OCCURRED WITH HARMONIC SCALPEL (HAR36). THE DEVICE WOULD 'BUZZ' WITH TISSUE CONTACT AND ANOTHER ERROR WOULD COME UP TO RELEASE PRESSURE. THE SAME ISSUE OCCURRED WITH SIX DEVICES USED IN THIS CASE. IN TOTAL, 400CC OF BLOOD WAS LOST IN THE LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) AND 200CC WAS LOST IN THE BILATERAL TUBAL LIGATION (BTL). NO TRANSFUSION WAS REQUIRED. A TUBE AND OVARY WERE REMOVED DUE TO BEING UNABLE TO MAKE THE DEVICES WORK PROPERLY. IN TOTAL, THE PROCEDURE WAS DELAYED 30 MINUTES IN THE LAVH AND 20 MINUTES IN THE BTL. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION WAS STABLE POST-PROCEDURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7140731 ↗
• InjuryDec 21, 2017Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message; Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING USE, TWO ERRORS TO RELEASE PRESSURE OCCURRED WITH HARMONIC SCALPEL (HAR36). THE DEVICE WOULD 'BUZZ' WITH TISSUE CONTACT AND ANOTHER ERROR WOULD COME UP TO RELEASE PRESSURE. THE SAME ISSUE OCCURRED WITH SIX DEVICES USED IN THIS CASE. IN TOTAL, 400 CC OF BLOOD WAS LOST IN THE LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) AND 200CC WAS LOST IN THE BILATERAL TUBAL LIGATION (BTL). NO TRANSFUSION WAS REQUIRED. A TUBE AND OVARY WERE REMOVED DUE TO BEING UNABLE TO MAKE THE DEVICES WORK PROPERLY. IN TOTAL, THE PROCEDURE WAS DELAYED 30 MINUTES IN THE LAVH AND 20 MINUTES IN THE BTL. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION WAS STABLE POST-PROCEDURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7140728 ↗
• InjuryDec 21, 2017Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message; Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING USE, TWO ERRORS TO RELEASE PRESSURE OCCURRED WITH HARMONIC SCALPEL (HAR36). THE DEVICE WOULD 'BUZZ' WITH TISSUE CONTACT AND ANOTHER ERROR WOULD COME UP TO RELEASE PRESSURE. THE SAME ISSUE OCCURRED WITH SIX DEVICES USED IN THIS CASE. IN TOTAL, 400CC OF BLOOD WAS LOST IN THE LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) AND 200CC WAS LOST IN THE BILATERAL TUBAL LIGATION (BTL). NO TRANSFUSION WAS REQUIRED. A TUBE AND OVARY WERE REMOVED DUE TO BEING UNABLE TO MAKE THE DEVICES WORK PROPERLY. IN TOTAL, THE PROCEDURE WAS DELAYED 30 MINUTES IN THE LAVH AND 20 MINUTES IN THE BTL. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION WAS STABLE POST-PROCEDURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7140727 ↗
• MalfunctionDec 21, 2017Split; Split

  IT WAS REPORTED THE PAD ON THE HARMONIC SCALPEL (HAR36) WAS CURLED AND SPLIT DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7140671 ↗
• MalfunctionDec 21, 2017Material Separation; Split; Material Separation; Split

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE TEFLON PAD TIP WAS NOTICED AS BREAKING AWAY FROM THE HARMONIC SCALPEL (HAR36). IT DID NOT FALL OFF IN THE PATIENT AND THE TEFLON PAD WAS REPORTED AS STILL ATTACHED TO THE JAW. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7140667 ↗
• InjuryDec 21, 2017Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message; Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING USE, TWO ERRORS TO RELEASE PRESSURE OCCURRED WITH HARMONIC SCALPEL (HAR36). THE DEVICE WOULD 'BUZZ' WITH TISSUE CONTACT AND ANOTHER ERROR WOULD COME UP TO RELEASE PRESSURE. THE SAME ISSUE OCCURRED WITH SIX DEVICES USED IN THIS CASE. IN TOTAL, 400CC OF BLOOD WAS LOST IN THE LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) AND 200CC WAS LOST IN THE BILATERAL TUBAL LIGATION (BTL). NO TRANSFUSION WAS REQUIRED. A TUBE AND OVARY WERE REMOVED DUE TO BEING UNABLE TO MAKE THE DEVICES WORK PROPERLY. IN TOTAL, THE PROCEDURE WAS DELAYED 30 MINUTES IN THE LAVH AND 20 MINUTES IN THE BTL. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION WAS STABLE POST-PROCEDURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7140448 ↗
• InjuryDec 21, 2017Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message; Energy Output To Patient Tissue Incorrect; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING USE, TWO ERRORS TO RELEASE PRESSURE OCCURRED WITH HARMONIC SCALPEL (HAR36). THE DEVICE WOULD 'BUZZ' WITH TISSUE CONTACT AND ANOTHER ERROR WOULD COME UP TO RELEASE PRESSURE. THE SAME ISSUE OCCURRED WITH SIX DEVICES USED IN THIS CASE. IN TOTAL, 400CC OF BLOOD WAS LOST IN THE LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) AND 200CC WAS LOST IN THE BILATERAL TUBAL LIGATION (BTL). NO TRANSFUSION WAS REQUIRED. A TUBE AND OVARY WERE REMOVED DUE TO BEING UNABLE TO MAKE THE DEVICES WORK PROPERLY. IN TOTAL, THE PROCEDURE WAS DELAYED 30 MINUTES IN THE LAVH AND 20 MINUTES IN THE BTL. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION WAS STABLE POST-PROCEDURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 7140446 ↗
• MalfunctionNov 16, 2017Break; Break

  IT WAS REPORTED THE TIP OF THE HARMONIC SCALPEL (HAR36) BROKE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7038064 ↗
• InjuryOct 17, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED THE HARMONIC SCALPEL (HAR36) DID NOT COMPLETELY SEAL THE VESSEL AND THE PATIENT WAS BLEEDING POST-OPERATION. THERE WAS NO DELAY IN THE ORIGINAL PROCEDURE. THE PATIENT WAS BROUGHT BACK INTO SURGERY AND THE VESSELS WERE SUCCESSFULLY SEALED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 6956721 ↗
• InjuryOct 17, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED THE HARMONIC SCALPEL (HAR36) DID NOT COMPLETELY SEAL THE VESSEL AND THE PATIENT WAS BLEEDING POST-OPERATION. THERE WAS NO DELAY IN THE ORIGINAL PROCEDURE. THE PATIENT WAS BROUGHT BACK INTO SURGERY AND THE VESSELS WERE SUCCESSFULLY SEALED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 6956650 ↗
• MalfunctionOct 16, 2017Detachment Of Device Component; Melted; Detachment Of Device Component; Melted

  IT WAS REPORTED THAT AFTER SEVERAL USES, A RESIDENT NOTICED THE HARMONIC SCALPEL (HAR36) BLADE TIP WAS MELTED/DAMAGED. NOTHING FELL INTO THE PATIENT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6953458 ↗
• MalfunctionOct 16, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED A HARMONIC SCALPEL (HAR36) TEFLON PAD CAME OFF OF THE DEVICE DURING THE PROCEDURE. THE PIECE FELL INTO THE PATIENT, BUT WAS IMMEDIATELY RETRIEVED WITHOUT OPENING THE PATIENT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6953411 ↗
• InjuryOct 12, 2017Melted; Environmental Particulates; Melted; Environmental Particulates

  IT WAS REPORTED THAT DURING THE CASE, SMOKE BEGAN TO FILL IN THE CAVITY AS A HARMONIC SCALPEL (HAR36) WAS GRABBING TISSUE. THEY HAD TO DE-INSUFFLATE THE CAVITY TO GET RID OF THE SMOKE. WHEN THE DEVICE WAS REMOVED, THE TEFLON PAD WAS REPORTED TO HAVE MELTED OFF. THERE WAS NO PATIENT INJURY AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6946505 ↗