SAPHYRE 7209686Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010470560), received between Dec 27, 2018 and Sep 24, 2024 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT DURING A JOINT CAVITY DEBRIDEMENT WHEN THE PROBE SAPHYRE WAND WAS USED FOR THE FIRST TIME, THE INSULATING LAYER WAS SPLIT INSIDE THE ARTICULAR CAVITY, THE WAND WAS QUICKLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN S+N BACKUP DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296525 ↗
• InjurySep 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, A LEFT SHOULDER ARTHROSCOPIC EXPLORATION AND CLEANING, ADHESION RELEASE, SUBACROMIAL BURSA RESECTION AND ACROMIOPLASTY WERE PERFORMED IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA. AFTER THE SURGERY WAS COMPLETED, AND THE INCISION HAD BEEN CLOSED. WHEN THE NURSE COUNTED THE SURGICAL ITEMS, IT WAS NOTICED, THAT THE ELECTRODE BLADE AT THE FRONT END FROM THE SAPHYRE PROBE WAS MISSING. AN X-RAY WAS PERFORMED AND REVIEWED ON THE SAME DAY. WHICH SUGGESTED, THERE WAS A METAL FOREIGN BODY UNDER THE PATIENT'S LEFT ACROMION, WITH A DIAMETER OF ABOUT 1.8 MM. ON THE MORNING OF (B)(6), THE PATIENT WAS SATISFIED WITH A RELIEF OF HIS SYMPTOMS. NO DISCOMFORT WAS REPORTED. SINCE THE REPORTED REMAINING FRAGMENTS WERE VERY SMALL, THE DOCTORS DID NOT CONSIDER THEM TO BE OF MUCH CONSEQUENCE. IT WAS THEN DECIDED, WITH THE PATIENT'S CONSENT, THAT AN ADDITIONAL OPERATION WOULD NOT BE SCHEDULED TO REMOVE THE REMAINING FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17821624 ↗
• InjuryNov 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP AND THE SHAFT OF THE PROBE SAPHYRE WAND, GOT SEPARATED WHEN USED FOR 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15791903 ↗
• InjuryNov 10, 2022Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE SAPHYRE PROBE ELECTRODE WAS FOUND BROKEN 5 MINUTES AFTER ENTERING THE JOINT CAVITY. THE BROKEN PARTS WERE TAKEN OUT USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. THE PATIENT IS REPORTED TO BE FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770439 ↗
• MalfunctionSep 27, 2022Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, IN THE JOINT CAVITY, THE SKIN OF THE PROBE SAPHYRE WAND CRACK AT THE BEGINNING OF THE ABLATION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491797 ↗
• MalfunctionAug 19, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, AFTER AN UBE OPERATION OF SPINE, THE TEMPERATURE OF THE PROBE SAPHYRE BLADE WAS TOO HIGH. SURGERY WAS FINISHED WITHOUT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259473 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC TREATMENT USING A SAPHYRE 90° PROBE; THE LENS OF THE ARTHROSCOPE GOT DAMAGED DUE TO IMPROPER OPERATION. IN CONSEQUENCE, THE LENS APERTURE BECAME SMALLER AFFECTING THE VISUAL FIELD MAKING IT INOPERABLE. THE SAPHYRE DID NOT BREAK INTO FRAGMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY CHANGING THE SURGICAL METHOD. THE SURGICAL METHOD CHANGED FROM ARTHROSCOPIC TO THE TRADITIONAL WHICH THE INCISION WAS LARGER. NO DELAYS NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976912 ↗
• MalfunctionJul 7, 2021Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING USE FOR 20 MINUTES, USING THE "PROBE SAPHYRE 90DEG", THE HEAD METAL HAD A DEFORMATION FRACTURE AND A RUBBER DEFORMATION CONTRACTURE. IT IS UNKNOWN IF THERE WAS A DELAY. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129703 ↗
• InjuryJan 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY, THE PROBE ELECTRODE FALL OFF. DELAY WAS GREATER THAN 30 MINUTES AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. THE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. 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 11256330 ↗
• MalfunctionJan 12, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE PROBE HEAD HAS NO POSITIVE ENERGY OUTPUT AND CANNOT BE USED WHILE BEING USED IN DEFAULT SETTINGS. THE PROBE HEAD IS FOR SINGLE USE. THE HOST SHUTDOWN AND RESTART STILL CAN NOT BE USED, FINALLY A NEW PROBE HEAD WAS USED TO COMPLETE THE SURGERY WITH A DELAY GREATER THAN 30 MINUTES. 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 11158139 ↗
• MalfunctionApr 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ARTHROSCOPY OF THE LEFT SHOULDER, JOINT CAVITY CLEANING, ACROMIOPLASTY, AND ROTATOR CUFF AVULSION SURGERY THE PROBE SAPHYRE TIP SHAFT SEPARATED WHEN IT WAS USED FOR 2 MINUTES. THE DEVICE BREAKS INSIDE THE PATIENT AND WAS RETRIEVED USING SUCTION. THERE WAS AN AVAILABLE BACKUP DEVICE. NO DELAY WAS REPORTED. NO PATIENT INJURY OR 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: Foreign Body In Patient

  MAUDE report 9984389 ↗
• MalfunctionSep 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC SURGERY, THE METAL PIECE DISAPPEARED, NO X-RAYS WERE PERFORMED TO CONFIRMED IF THE METAL PIECE MELT OR FELL OFF INSIDE THE PATIENT'S ANATOMY. NO PATIENT INJURIES REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8957004 ↗
• MalfunctionMay 24, 2019Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE TIP OF THE CUTTER HEAD WAS BROKEN AND FALL OFF IN THE JOINT CAVITY WHEN USE. THE BROKEN PART HAS BEEN REMOVED WITH A CURVED FORCEPS WITH THE HELP OF THE ARTHROSCOPY, RESULTING IN LONGER SURGERY OPERATION TIME. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8641189 ↗
• MalfunctionDec 27, 2018Overheating of Device

  IT WAS REPORTED THAT, DURING CLEANING, THE PROBE WAS HOT GIVEN THAT THE CONTROLLER ERROR WAS NOT DISPLAYED. THERE WAS A BACK-UP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE, WITH NEITHER SIGNIFICANT DELAY NOR PATIENT/USER INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8200102 ↗