NA 72200081Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010555687), received between Jan 10, 2019 and Dec 3, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Flaked” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A TISSUE REMOVAL PROCEDURE, THE INCISOR PLUS ELITE BLADE 5.5MM HAD LOSS OF METALLIC DEBRIS. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING THE SAME PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704081 ↗
• MalfunctionJul 17, 2025Material Fragmentation; Material Deformation; Physical Resistance/Sticking; Material Fragmentation; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING FOR AN ARTHROSCOPY, THE INNER COMPONENTS ON THE INCISOR PLUS ELITE BLADE WERE TIGHTLY INSERTED AND THEY WERE ALMOST IMPOSSIBLE TO REMOVE. THE BLADE COULDN'T BE INSERTED, AS IT DIDN'T ROTATE CLOCKWISE OR COUNTERCLOCKWISE, NOR DID IT ROTATE IN OSCILLATION MODE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538982 ↗
• MalfunctionOct 23, 2023Break; Break

  IT WAS REPORTED THAT DURING A CUFF/SHOULDER PROCEDURE, THE INCISOR BLADE BROKE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990675 ↗
• InjuryMar 15, 2023Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, SHORTLY AFTER USE BEGAN, THE INCISOR BLADE MADE A NOISE AS IF IT WAS SEIZED AND THEN DISPERSED METAL PARTICLES INTO THE KNEE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PARTICLES WERE REMOVED BY SUCTION. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED AND IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547094 ↗
• InjuryApr 7, 2022Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC LIGAMENTOPLASTY OF THE RIGHT KNEE, IT WAS FOUND THAT FILINGS OF THE INCISOR BLADE WERE APPEARING IN THE JOINT. FOLLOWING THIS FINDING, THE SURGEON STOPPED THE ARTHROSCOPY AND PROCEEDED TO AN OPEN ARTHROTOMY OF THE KNEE IN ORDER TO CLEAN AND REMOVE ALL FOREIGN BODIES, THIS USING SYRINGES OF WATER AND COMPRESSES TO CLEAN UP IN LARGE VOLUMES AND A SUCTION CANNULA TO EVACUATE AND WASHING WITH BETADINE SERUM. AFTER CHECKING THE BLADE, THE SURGEON FOUND THAT THERE WAS FRICTION BETWEEN THE BLADE AND ITS SHEATH WHICH CAUSED WEAR IN SEVERAL AREAS OF THE BLADE BODY. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046044 ↗
• MalfunctionSep 22, 2021Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT, DURING ARTHROSCOPY, AN INCISOR PLUS ELITE BLADE WAS NOT WORKING BECAUSE THE INNER BLADE WAS BENT AND CRACKED EXTERNAL TO PATIENT. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512245 ↗
• MalfunctionFeb 12, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY THE INCISOR PLUS ELITE BLADE WAS OSCILLATING. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A "SHEDDING, FLAKING" WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9702305 ↗
• MalfunctionFeb 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE TIP OF THE BLADE BROKE OFF, ENDING UP IN THE SPACE BETWEEN THE DISTAL END OF THE FEMUR AND THE PROXIMAL END OF THE TIBIA. THE PIECES OF THE BLADE WAS REMOVED USING BASKET TWEEZERS. IT IS UNKNOWN IF THERE WAS A DELAY OR BACK-UP DEVICE AVAILABLE. NO PATIENT INJURIES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9673205 ↗
• MalfunctionJan 11, 2019Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT DURING THE SURGERY THE KNIFE DOES NOT WORK PROPERLY BECAUSE OF A DIFFICULT ROTATION OF THE KNIFE, THIS CAUSED THAT THE KNIFE HEAD RELEASE HEAT (OVERHEATING, AN ERROR MESSAGE : KNIFE BLOCK SEEN). NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. PROCEDURE WAS COMPLETED USING THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8242083 ↗
• MalfunctionJan 10, 2019Overheating of Device; Activation Problem

  IT WAS REPORTED THAT DURING A SURGERY, THE KNIFE DID NOT WORK PROPERLY (DIFFICULT ROTATION). THE KNIFE HEAD PRESENTED HEAT RELEASE WITH ABNORMAL FRICTION NOISES, THE DEVICE BECOME OVERHEAT WHEN THIS WAS TOUCHED AND AN ERROR MESSAGE WAS DISPLAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETE WITH THE SAME DEVICE. NO PATIENT INJURY OR DELAY IN THE CASE WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8234210 ↗