N/A HAR1136Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327586589), received between Nov 19, 2024 and Sep 25, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906261 ↗
• InjuryFeb 4, 2026Use of Device Problem; Failure to Seal

  IT WAS REPORTED THAT THE SURGICAL TEAM OBSERVED PROLONGED AND POOR TISSUE SEALING AND THIS REPROCESSED HARMONIC ALARMED REMOVE INSTRUMENT AND CLEAN TIPS EVEN THOUGH THERE WAS NO CHAR ON TIPS TO CLEAN. THIS PRODUCT HAD POOR TISSUE SEALING AND CAUSED BLEEDING. CASE TRANSITIONED TO AN OPEN PROCEDURE. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24263373 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HAR1136 PROMPTED TO CLEAN INSTRUMENT THEN DIRECTLY TO REPLACE INSTRUMENT. THEY TROUBLESHOOTED BY CLEANING THE JAWS, RUNNING TEST EXTERIOR TO THE BODY AND STILL WERE PROMPTED TO REPLACE INSTRUMENT. SURGEON FINISHED USING A L HOOK TECHNIQUE. THE BLADE WAS NOTICED TO BREAK DURING THE PROCEDURE. IT WAS BELIEVED TO HAVE INTERACTED WITH A STAPLE WHICH LIKELY CAUSED THE BREAKAGE.

  Patient problems: Insufficient Information

  MAUDE report 23843858 ↗
• MalfunctionNov 25, 2025Fracture; Fracture

  IT WAS REPORTED FOR A HAR1136: IN THE MIDDLE OF THE CASE (HYSTERECTOMY), AS THEY WERE GOING AROUND THE CUFF, THE DEVICE KEPT SHOWING ¿REMOVE INSTRUMENT FROM PATIENT¿ AND AFTER SEVERAL TIMES OF THIS DISPLAYING IT SHOWED ¿REPLACE INSTRUMENT¿ AND IT WAS REPLACED WITH A STRYKER HARMONIC. IT WAS FURTHER REPORTED THE BLADE WAS INTACT PRIOR TO RETURN SHIPMENT TO STRYKER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645292 ↗
• MalfunctionNov 25, 2025Fracture; Fracture

  IT WAS REPORTED FOR A HAR1136: IN THE MIDDLE OF THE CASE (HYSTERECTOMY), AS THEY WERE GOING AROUND THE CUFF, THE DEVICE KEPT SHOWING ¿REMOVE INSTRUMENT FROM PATIENT¿ AND AFTER SEVERAL TIMES OF THIS DISPLAYING IT SHOWED ¿REPLACE INSTRUMENT¿ AND IT WAS REPLACED WITH A STRYKER HARMONIC. IT WAS FURTHER REPORTED THE BLADE WAS INTACT PRIOR TO RETURN SHIPMENT TO STRYKER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645275 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THE HAR1136 PROMPTED MESSAGE TO REPLACE INSTRUMENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, AND THE EXTENDED PROCEDURE TIME REPORTED WAS ONE MINUTE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605512 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS AN ERROR MESSAGE ON THE GENERATOR TO REPLACE THE INSTRUMENT. THE DEVICE WAS RECEIVED BY STRYKER WITH A BROKEN TIP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS ONE MINUTE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596825 ↗
• MalfunctionNov 5, 2025Fracture; Fracture

  IT WAS REPORTED A HAR1136 PROMPTED AN ERROR CODE, "REMOVE FROM PATIENT" AND "REPLACE DEVICE" WHILE USING THE DEVICE. INVESTIGATION OF THE RETURNED COMPLAINT DEVICE IDENTIFIED A LARGE CHIP ON THE DISTAL TIP OF THE BLADE. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23482327 ↗
• MalfunctionOct 29, 2025Fracture; Fracture

  IT WAS REPORTED THE HAR DEVICE FAILED. IT WAS FURTHER REPORTED THE PRODUCT STOPPED WORKING DURING A PROCEDURE. IT WAS REPORTED THE BLADE WAS INTACT PRIOR TO RETURN SHIPMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TWO MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417933 ↗
• MalfunctionOct 29, 2025Fracture; Fracture

  IT WAS REPORTED THE HAR DEVICE FAILED. IT WAS FURTHER REPORTED THE PRODUCT WORKED ORIGINALLY THEN FAILED. IT WAS REPORTED THE BLADE WAS INTACT PRIOR TO RETURN SHIPMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TWO MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417931 ↗
• MalfunctionOct 29, 2025Fracture; Fracture

  IT WAS REPORTED THE HAR DEVICE FAILED. IT WAS FURTHER REPORTED THE PRODUCT STOPPED WORKING AND AN ERROR POPPED UP STATING TO "REPLACE ITEM." IT WAS REPORTED THE BLADE WAS INTACT PRIOR TO RETURN SHIPMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TWO MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416603 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  IT WAS REPORTED THE HAR DEVICE FAILED. IT WAS FURTHER REPORTED THE MACHINE SAID REPLACE INSTRUMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE EXTENDED PROCEDURE TIME WAS TWO MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373008 ↗
• MalfunctionOct 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HAR DEVICE FAILED AND STOPPED WORKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TWO MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350765 ↗
• MalfunctionJul 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HAR1136 GENERATOR GIVES ERROR AFTER TOUCHING METAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TWO MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589560 ↗
• MalfunctionJul 17, 2025Fracture; Fracture

  IT WAS REPORTED THE HAR1136 STOPPED WORKING AFTER IT HIT A METAL KOH CUP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TWO MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537366 ↗
• MalfunctionJul 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HAR1136 DEVICE STOPPED WORKING DURING MID CASE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TWO MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537156 ↗
• InjuryJun 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE FUNCTIONED NORMALLY FOR THE MAJORITY OF THE CASE UNTIL THERE WAS AN ISSUE IN WHICH THE GENERATOR PROMPTED STAFF TO REMOVE THE DEVICE FROM THE PATIENT. UPON INSPECTION, IT WAS NOTED THAT A FRAGMENT OF THE BLADE WAS MISSING. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT AND PLACED INTO A CONTAINER TO BE SHIPPED TO THE MANUFACTURER FOR INVESTIGATION. THE FRACTURE OCCURRED DURING A HYSTERECTOMY WHILE THE JAWS WERE OPEN, AND THE BACK CUTTING METHOD WAS USED TO CUT TISSUE AGAINST A METAL RUMI. IT WAS NOTED THAT THE ACTUATING BLADE SHOULD AVOID CONTACT WITH PLASTIC AND METAL WHILE THE JAWS ARE BEING ACTIVATED, AS PER THE MANUFACTURER'S INSTRUCTIONS FOR USE (IFU). AS REPORTED, X-RAYS WERE USED TO ENSURE NO MATERIAL WAS LEFT POST OP. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND EXTENDED PROCEDURE TIME REPORTED WAS 35 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332963 ↗
• MalfunctionApr 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HAR1136 DEVICE PRODUCED AN ERROR IN THE MIDDLE OF USE. AS REPORTED, THE DEVICE WAS REPLACED WITH OEM. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764082 ↗
• MalfunctionMar 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HAR1136 HAD ISSUES WITH THE JOB NOT FUNCTIONING PROPERLY DUE TO TISSUE BUILT UP IN THE JAWS. PER THE SALES REPRESENTATIVE, THE CUSTOMER DID NOT INDICATE THAT THE BLADE WAS FRACTURED IN THE PATIENT OR DURING PROCEDURE AND THE COMPLAINT WAS STATING THAT DEVICE STOPPED WORKING BUT NOT THAT THE JAWS WERE FRACTURED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574466 ↗
• MalfunctionJan 15, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT THE HAR1136 WAS WORKING FOR A PERIOD OF TIME DURING THE PROCEDURE THEN STOPPED WORKING. AS REPORTED, THE PROCEDURE WAS COMPLETED WITH ANOTHER STRYKER DEVICE. PER THE SALES REP, THEY REFERENCED THAT IT STOPPED WORKING AFTER A PERIOD OF TIME IN USE BUT IT WAS NOT DUE TO THE JAWS BREAKING OR ANY PIECE OF THE DEVICE BREAKING OFF DURING THE USE OF THE DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162245 ↗
• MalfunctionJan 9, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT WHEN PLUGGED IN, THE HAR1136 WASN'T CALIBRATING OR REGISTERING ON THE GENERATOR. AS REPORTED, A GEN11 GENERATOR, 2018-1 SOFTWARE. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21115554 ↗
• MalfunctionJan 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HAR1136 INSTRUCTED TO REMOVE FORM PATIENT DURING USE, CLEAN BLADE, THEN PROMPTED TO REPLACE DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095979 ↗
• MalfunctionJan 7, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT WHEN PLUGGED IN, THE HAR1136 WASN'T CALIBRATING OR REGISTERING ON THE GENERATOR. GEN11 GENERATOR, 2018-1 SOFTWARE. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095977 ↗
• MalfunctionNov 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE FAILED AFTER MINIMAL USE AND ONLY A COUPLE OF CUTS WERE DONE BEFORE THE DEVICE PROMPTED TO BE CLEANED. THE DEVICE WAS CLEANED AND PROMPTED TO REPLACE. UPON INVESTIGATION OF THE COMPLAINT DEVICE, THE BLADE TIP FELL OFF OF THE COMPLAINT DEVICE DURING DISASSEMBLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728796 ↗