Medline HAR36MRRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888277408708), received between Nov 8, 2016 and Jul 17, 2019 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2019Device Fell

  IT WAS REPORTED THAT THE TEFLON PAD ON THE DISTAL JAW OF THE REPROCESSED ETHICON HARMONIC ACE®+ SHEARS FELL OFF INTO PATIENT/SURGICAL SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798050 ↗
• MalfunctionJul 16, 2019Device Fell

  IT WAS REPORTED THAT THE TEFLON PAD ON THE DISTAL JAW OF THE REPROCESSED ETHICON HARMONIC ACE®+ SHEARS FELL OFF INTO PATIENT/SURGICAL SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794547 ↗
• InjuryJun 21, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE REPROCESSED ETHICON HARMONIC ACE®+ SHEARS, W/O ADAPTIVE TISSUE TECHNOLOGY 36CM, WERE USED FOR SEALING, FILM CAME OFF THE JAWS AND STUCK TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8722053 ↗
• MalfunctionApr 12, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TEFLON PADS OF TWO REPROCESSED ETHICON HARMONIC ACE®+ SHEARS FELL OFF DURING USE.

  Patient problems: No Information

  MAUDE report 8510111 ↗
• MalfunctionMar 25, 2019Break; Device Fell

  IT WAS REPORTED THAT THE TIP OF THE REPROCESSED ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM BROKE OFF AND FELL INTO THE SURGICAL SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448278 ↗
• MalfunctionDec 12, 2018Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A LAP SLEEVE, THE REPROCESSED HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM WOULD NOT SEAL A VESSEL. PROCEDURE WENT OVER THE EXPECTED TIME AND PATIENT HAD TO BE ADMINISTERED MORE ANESTHESIA MEDICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156766 ↗
• InjuryJun 14, 2017Material Fragmentation; Material Fragmentation

  WE RECEIVED A REPORT INDICATING WHILE USING A REPROCESSED HARMONIC SCALPEL, THE BLACK TISSUE PAD LOCATED ON THE DISTAL TIP, DETACHED DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6640780 ↗
• MalfunctionMar 14, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  A USER REPORTED THAT SHORTLY AFTER BEGINNING USE OF A REPROCESSED HARMONIC SCALPEL, THE GENERATOR BEEPED AND DISPLAYED AN ERROR MESSAGE TO "RELAX PRESSURE". THE DEVICE COULD NOT BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6404860 ↗
• MalfunctionMar 14, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  A USER REPORTED THAT SHORTLY AFTER BEGINNING USE OF A REPROCESSED HARMONIC SCALPEL, THE GENERATOR BEEPED AND DISPLAYED AN ERROR MESSAGE TO "RELAX PRESSURE". THE DEVICE COULD NOT BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6404859 ↗
• MalfunctionMar 14, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  A USER REPORTED THAT SHORTLY AFTER BEGINNING USE OF A REPROCESSED HARMONIC SCALPEL, THE GENERATOR BEEPED AND DISPLAYED AN ERROR MESSAGE TO "RELAX PRESSURE". THE DEVICE COULD NOT BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6404858 ↗
• InjuryMar 14, 2017Material Fragmentation; Device Displays Incorrect Message; Material Fragmentation; Device Displays Incorrect Message

  WE RECEIVED A REPORT INDICATING THAT THE BLACK TISSUE PAD LOCATED ON THE DISTAL TIP OF A REPROCESSED HARMONIC SCALPEL DETACHED DURING USE. THE PHYSICIAN WAS ABLE TO FIND AND REMOVE THE TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6404857 ↗
• InjuryMar 14, 2017Material Fragmentation; Device Displays Incorrect Message; Material Fragmentation; Device Displays Incorrect Message

  A USER REPORTED THAT SHORTLY AFTER BEGINNING USE OF A REPROCESSED HARMONIC SCALPEL, THE GENERATOR BEEPED AND DISPLAYED AN ERROR MESSAGE TO "RELAX PRESSURE". THE DEVICE COULD NOT BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6404856 ↗
• InjuryMar 3, 2017Material Fragmentation; Material Fragmentation

  WE RECEIVED A REPORT INDICATING THAT THE BLACK TISSUE PAD LOCATED ON THE DISTAL TIP OF A REPROCESSED ULTRASONIC SCALPEL DETACHED DURING A HYSTERECTOMY. HOWEVER, THE PHYSICIAN WAS ABLE TO FIND AND REMOVE THE TIP DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378203 ↗
• MalfunctionNov 8, 2016Material Separation; Material Separation

  MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE GENERATOR INITIATED AN ERROR CODE TO "RELAX PRESSURE" DURING THE USE OF A REPROCESSED ETHICON HARMONIC ACE+ LAPAROSCOPIC SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY, MODEL HAR36M. THEN PART OF THE TISSUE PAD LOCATED ON THE DISTAL TIP DETACHED FROM THE DEVICE AND WAS RETRIEVED BY THE SURGEON. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE, THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6088206 ↗
• MalfunctionNov 8, 2016Material Separation; Material Separation

  MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE GENERATOR INITIATED AN ERROR CODE TO "RELAX PRESSURE" DURING THE USE OF A REPROCESSED ETHICON HARMONIC ACE+ LAPAROSCOPIC SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY, MODEL HAR36M. THEN PART OF THE TISSUE PAD LOCATED ON THE DISTAL TIP DETACHED FROM THE DEVICE AND WAS RETRIEVED BY THE SURGEON. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE, THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6088191 ↗
• MalfunctionNov 8, 2016Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT A REPROCESSED ETHICON HARMONIC ACE+ LAPAROSCOPIC SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY, MODEL HAR36M, DID NOT CONNECT PROPERLY TO THE GENERATOR, AND THAT THE DEVICE WOULD NOT ACTIVATE DURING USE. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE; THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6085810 ↗