VULCAN SAPHYRE 7210111Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010481498), received between Jul 26, 2018 and Dec 16, 2022 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY, THE SAPHYRE PROBE HAD AN ELECTRICAL LEAKAGE, THERE WERE SPARKS. 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 15996471 ↗
• InjuryJun 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE INSULATION RUBBER OF THE SAPHYRE II PROBE FELL OFF. THE FALLEN OFF RUBBER WAS REMOVED BY SUCTION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876856 ↗
• InjuryMay 8, 2022Peeled/Delaminated; Electrical Shorting; Peeled/Delaminated; Electrical Shorting

  IT WAS REPORTED THAT DURING A KNEE DEBRIDEMENT PROCEDURE USING SAPHYRE PROBE, AN ELECTRICAL LEAKAGE OCCURRED. THE SHEATHING OF THE WAND WAS PEELING, AND THERE WAS AN ELECTRIC SHOCK FEELING. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332568 ↗
• MalfunctionNov 15, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE PROBE, SAPHYRE, DID NOT GET AN OUTPUT ENERGY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815004 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR REPAIR, INSTRUMENTS INSIDE PATIENT, THE WAND SHAFT OF THE PROBE WAS BROKEN, CANNOT WORK. THE PATIENT WAS UNDER ANESTHESIA WHEN THE DELAY OCCURRED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. A SIGNIFICANT DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533104 ↗
• MalfunctionJul 15, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, INSIDE THE PATIENT, THE HANDLE OF THE SAPHYRE PROBE WAS GETTING HOT. THE CUSTOMER CONTINUOUSLY USED THE DEVICE TO WRAP A GAUZE WHICH IS WET WITH WATER, ON THE HANDLE OF THE PROBE. THE CUSTOMER STOPPED USING THE PROBE SINCE THE DEVICE GAVE OUT SMOKE FROM THE TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO SURGICAL DELAY. NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12175835 ↗
• InjuryFeb 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A LEFT SHOULDER ARTHROSCOPIC SURGERY, THE PROBE SAPHYRE II WAS USED, AND IT WAS FOUND THAT THE INSULATION RUBBER OF THE PROBE FELL OFF. THE SURGEON IMMEDIATELY SUSPENDED THE OPERATION AND TOOK OUT THE FALLEN OFF RUBBER. NO OTHER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11369665 ↗
• MalfunctionDec 4, 2018Device Fell

  IT WAS REPORTED THAT, DURING A SURGERY, THE DEVICE FRONT MATERIAL FELL OFF. ALL PIECES WERE REMOVED. THE REPORTED DELAY RESULT IN A LITTLE EXTENDED EXPOSURE TO ANESTHESIA TO THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8131360 ↗
• MalfunctionJul 26, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ELECTRODE HEAD FELL OFF INTO THE KNEE JOINT CAVITY. THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7723302 ↗