SAPHYRE 7210113Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010483287), received between Sep 26, 2019 and Nov 20, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Arcing” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2020Overheating of Device; Electrical Shorting; Overheating of Device; Electrical Shorting

  IT WAS REPORTED THAT DURING AN ACL AFTER THE WAND WAS CONNECTED, THE TIP SPARK AND DEVICE OVERHEATED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS 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; No Known Impact Or Consequence To Patient

  MAUDE report 10879962 ↗
• MalfunctionJan 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE INSULATION COATING OF THE SHAFT WAS PEELED OFF DURING USE. ALL PEELED PARTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME WAND. NO DELAY AND NO PATIENT INJURY WERE 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 9617035 ↗
• MalfunctionSep 26, 2019Arcing; Arcing

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE WAND WAS USED FOR SOFT TISSUE ABLATION, THERE WAS AN ARC AT THE RETURN ELECTRODE IT EMITTED RED LIGHT. THERE WAS A 5 MIN DELAY. A BACKUP DEVICE WAS AVAILABLE, NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9126230 ↗