NA 72200829Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 03596010573520), received between Dec 18, 2017 and Sep 18, 2024 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (8 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 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE TROCAR OF THE HIGH FLOW CANNULA BECAME DISASSEMBLED WHEN PLACING THE CAMERA INSIDE THE JOINT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A 40 MINUTE SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251931 ↗
• MalfunctionAug 6, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, ONCE PATIENT WAS ANESTHETIZED AND THE PROCEDURE BEGAN THE SURGICAL SUPPORT CONNECTED THE CABLES TO THE TOWER AND REALIZED THAT THE LENS WAS MISSING, THE SURGICAL SUPPORT WENT TO THE CENTRAL STERILIZATION WHERE IT WAS FOUND THAT THE LENS WAS IN ONE OF THE UNSTERILIZED CONTAINERS. THE SPECIALIST DECIDED TO CANCEL THE PROCEDURE. THE PATIENT'S ANESTHESIA WAS REVERSED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924209 ↗
• InjuryDec 7, 2023Excess Flow or Over-Infusion; Material Integrity Problem; Excess Flow or Over-Infusion; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE INVOLVING A DYONICS 25 CONTROL UNIT, THE PUMP FLUID LEAKED INTO THE JOINT. IT APPEARED THAT THE CANNULA AND OBTURATOR'S SHEATH WAS BROKEN, BUT THE FLUID WAS ACTUALLY SHOOTING OUT OF THE SKIN INCISION/PORTAL WHERE THE SHEATH WAS LOCATED. THE PRESSURE WAS REDUCED TO 35, AND A REPLACEMENT PUMP WAS BROUGHT IN BUT NOT USED, AS FLUID HAD ALREADY SPREAD INTO THE PATIENT'S LEG. UPON REMOVING THE DRAPING, APPROXIMATELY 2L OF FLUID WAS FOUND IN THE THIGH. THIS EXTENSIVE FLUID EXTRAVASATION LED TO SEVERE SWELLING, CAUSING TRAUMATIC INJURY TO NERVES AND TISSUES. THE PROCEDURE WAS CANCELLED DUE TO THE SURGEON'S CONCERNS ABOUT POTENTIAL COMPARTMENT SYNDROME AND PATIENT SAFETY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION BUT NEEDED 5.5 HOURS OF MONITORING IN THE RECOVERY ROOM. AS OF NOW, THE PATIENT HAS NOT RECOVERED SUFFICIENTLY TO RESCHEDULE THE PROCEDURE.

  Patient problems: Extravasation; Insufficient Information; Nerve Damage

  MAUDE report 18286149 ↗
• InjuryNov 22, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, WHEN THE SURGEON MADE A LITTLE STRENGTH TO LOOSEN THE DOUBLE VALVE CANNULA, IT BROKE. THE BROKEN PART WAS REMOVED FROM THE PATIENT. THE SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15843461 ↗
• InjuryDec 15, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY BY ENTERING THE LENS INTO THE CANNULA INSIDE THE ARTICULATION THE PHYSICIAN NOTICED AT THE SCREEN AS IF THE LENS WAS BROKEN. THE PHYSICIAN REMOVED THE LENS AND A BLACK STAIN OF DIRT ON THE CANNULA WAS OBSERVED. ANOTHER DEVICE WAS USED IN ORDER TO CONCLUDE THE PROCEDURE. NON-SIGNIFICANT DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED AND PATIENT´S HEALTH CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13009310 ↗
• InjuryOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING SURGERY, AT THE MOMENT THE "6MM HIGH FLOW CANNULA" WAS INSERTED IN THE POINT, THE SURGICAL STAFF REALIZED THAT THE METAL PART IN THE CANNULA WAS THROUGH THE COAGULATION. THEY IDENTIFIED THAT WAS LOOSE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO ADDITIONAL COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10737739 ↗
• MalfunctionAug 26, 2020Corroded; Corroded

  IT WAS REPORTED THAT THE CANNULA WAS RUSTY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10457283 ↗
• MalfunctionAug 26, 2020Corroded; Corroded

  IT WAS REPORTED THAT THE CANNULA WAS RUSTY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10457178 ↗
• MalfunctionMay 7, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT THE CANNULA WAS LEAKING WATER. THERE WAS NO BACKUP AVAILABLE AND NO DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8587428 ↗
• MalfunctionApr 23, 2019Corroded

  IT WAS REPORTED THAT DURING USE THE DEVICE WAS FOUND TO BE RUSTED IN THE INNER CORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8540066 ↗
• MalfunctionJul 24, 2018Contamination

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716249 ↗
• MalfunctionJul 24, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716222 ↗
• MalfunctionJul 24, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716142 ↗
• MalfunctionJul 24, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716083 ↗
• MalfunctionJul 24, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716043 ↗
• MalfunctionJul 24, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716021 ↗
• MalfunctionJul 24, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715633 ↗
• MalfunctionJul 24, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715457 ↗
• MalfunctionJul 24, 2018Peeled/Delaminated

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7715404 ↗
• MalfunctionJul 24, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715216 ↗
• MalfunctionJul 24, 2018Material Fragmentation

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715139 ↗
• MalfunctionJul 12, 2018Peeled/Delaminated

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. IT WAS THINKING THAT THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7681686 ↗
• MalfunctionFeb 24, 2018Leak/Splash

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING BETWEEN FAUCET IN AND OUT. THERE WAS NO BACK UP AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7294277 ↗
• MalfunctionDec 18, 2017Disassembly

  IT WAS REPORTED DURING THE PROCEDURE THE CANNULA DID NOT ROTATE AND WAS DISASSEMBLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7124736 ↗