SAPHYRE 7209685Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010470287), received between Dec 29, 2017 and Nov 4, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE TEMPERATURE OF THE SAPHYRE PROBE WAS TOO HIGH AFTER USING IT FOR MORE THAN 10 MINUTES, THE SURGEON WAS AFRAID TO USE IT ANYMORE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598640 ↗
• InjuryJun 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPIC EXPLORATION AND MENISCECTOMY, THE FRONT END OF A PROBE SAPHYRE WAND FELL OFF INTO THE BODY CAVITY. THE DOCTOR CAREFULLY LOOKED FOR THE FALLEN PART TO MAKE SURE THERE WAS NO RESIDUE IN THE PATIENT, THE RESIDUES WERE REMOVED USING TWEEZER. SURGERY WAS RESUMED WITH A BACK-UP DEVICE, AFTER A DELAY GREATER THAN 30 MIN. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594476 ↗
• InjuryAug 8, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A BILATERAL ARTHROSCOPY AND BILATERAL HIGH TIBIAL OSTEOTOMY, THE ELECTRODE OF THE PROBE FELL INTO THE PATIENT. ALTHOUGH THERE WAS NO SIGNIFICANT DELAY, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292235 ↗
• MalfunctionDec 29, 2017Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING A HIP LABIAL REPAIR SURGERY IT WAS FOUND THAT THE HANDLE OF THE PROBE WAS OVERHEATED AND SCALDING, AS WELL AS SLIGHT SMOKE/STEAM WAS OBSERVED. FINALLY, A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153752 ↗