N/A 1884002Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20681490047443), received between May 11, 2017 and Oct 6, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2022Break; Break

  HEALTHCARE PROFESSIONAL REPORTED THAT AS PER NURSING STAFF, THE BLADE WAS BEING USED DURING SINUS SURGERY WITH THE HANDPIECE. THE TIP OF THE BLADE BROKE OFF AND THE METAL TIP WAS RETRIEVED IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550489 ↗
• MalfunctionAug 10, 2018Break; Break

  THE CUSTOMER REPORTED THAT THE TIP OF THE BLADE BROKE WITHIN 30 SECONDS OF USE DURING A FESS PROCEDURE. NO FRAGMENTS REMAINED IN THE PATIENT OR OPERATING AREA, AND A NEW BLADE WAS OPENED TO CONTINUE THE SURGERY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7774143 ↗
• MalfunctionJul 3, 2018Material Separation; Material Separation

  A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TIP OF THE BLADE BROKE IN THE BEGINNING OF THE SURGERY. IT WAS CONFIRMED THERE WAS NO FRAGMENT IN THE OPERATION AREA. THE DOCTOR USED ANOTHER NEW BLADE TO COMPLETE THE SURGERY AND THERE WAS A DELAY OF ABOUT 3 MINUTES. IT WAS THE INITIAL USE OF THE BLADE. THE PROCEDURE WAS A UVULOPALATOPHARYNGOPLASTY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7661089 ↗
• MalfunctionMay 9, 2018Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE TIP OF THE BLADE BROKE OFF. THE TIP WAS RETRIEVED. THERE WAS A DELAY OF LESS THAN 10 MINUTES AND NO PATIENT INJURY OR IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500276 ↗
• MalfunctionDec 22, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE XPS BLADE SNAPPED PREOPERATIVE. THE CUSTOMER REFUSED TO RETURN THE DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7142919 ↗
• MalfunctionOct 12, 2017Break; Break

  THE CUSTOMER REPORTED THAT A BLADE BROKE DURING USE. THERE WAS NO PATIENT IMPACT OR INJURY. THERE CUSTOMER ALSO REPORTED THAT TWO SIMILAR EVENTS OCCURRED PREVIOUSLY. CASE 1 OF 3 WAS FILED UNDER REGULATORY REPORT # 3004209178-2017-20317 (MEDTRONIC INTERNAL REFERENCE NUMBER 702059037). CASE 2 OF 3 WAS FILED UNDER REGULATORY REPORT # 3004209178-2017-20318 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)). THIS REGULATORY REPORT IS BEING FILED FOR CASE 3 OF 3 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6945839 ↗
• MalfunctionSep 29, 2017Material Fragmentation; Material Fragmentation

  THE PHYSICIAN REPORTED THAT BLADES BROKE AT THE TIP TWICE LAST MONTH. THE FRAGMENTS THAT RESULTED FROM THE BREAK IN BOTH CASES WERE SAFELY REMOVED FROM THE PATIENT WITHOUT NEEDING X-RAY. THE PATIENTS ON BOTH CASES DID NOT HAVE PARTICULARLY HARD BONE. ON BOTH CASES IT WAS AROUND THE ETHMOID CAVITY. ONE PATIENT MAY HAVE HAD POLYPS AND OTHER JUST CHRONIC SINUS SINUSITIS. EVENT DATES FOR THESE TWO CASES ARE UNKNOWN. ADDITIONAL INFORMATION RECEIVED THAT A SIMILAR INCIDENT HAPPENED IN A THIRD CASE ON (B)(6) 2017. CASE 1 OF 3 WAS FILED UNDER REGULATORY REPORT # 3004209178-2017-20317 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)). THIS REGULATORY REPORT IS BEING FILED FOR CASE 2 OF 3 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)). A THIRD REGULATORY REPORT WILL BE FILED FOR CASE 3 OF 3 THAT OCCURRED ON (B)(6) 2017. (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6903662 ↗
• MalfunctionSep 29, 2017Break; Material Fragmentation; Break; Material Fragmentation

  THE PHYSICIAN REPORTED THAT BLADES BROKE AT THE TIP TWICE LAST MONTH. THE FRAGMENTS THAT RESULTED FROM THE BREAK IN BOTH CASES WERE SAFELY REMOVED FROM THE PATIENT WITHOUT NEEDING X-RAY. THE PATIENTS ON BOTH CASES DID NOT HAVE PARTICULARLY HARD BONE. ON BOTH CASES, IT WAS AROUND THE ETHMOID CAVITY. ONE PATIENT MAY HAVE HAD POLYPS AND OTHER JUST CHRONIC SINUS SINUSITIS. EVENT DATES FOR THESE TWO CASES ARE UNKNOWN. ADDITIONAL INFORMATION RECEIVED THAT A SIMILAR INCIDENT HAPPENED IN A THIRD CASE ON (B)(6) 2017. THIS REGULATORY REPORT IS BEING FILED FOR CASE 1 OF 3 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)). ANOTHER REGULATORY REPORT WILL BE FILED FOR CASE 2 OF 3 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)). A THIRD REGULATORY REPORT WILL BE FILED FOR CASE 3 OF 3 THAT OCCURRED ON (B)(6) 2017. (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6903609 ↗
• MalfunctionJun 7, 2017Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT INTRAOPERATIVE A BLADE BROKE DURING THE SURGERY. NO FRAGMENT WAS FOUND IN THE PATIENT. THE OPERATION WAS DELAYED FOR LESS THAN 10 MINUTES. ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE TIP BROKE, BUT IS STILL ATTACHED TO THE SHAFT; THERE WERE NO FRAGMENTS. THERE WAS NO PATIENT IMPACT. THE PRODUCT ANALYSIS OF THE DEVICE INDICATES THAT TIP OF THE BLADE BROKE OFF NOT ATTACHED, AND NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619391 ↗
• MalfunctionMay 11, 2017Material Fragmentation; Material Fragmentation

  THE PHYSICIAN REPORTED THAT DURING A FESS THE TIP OF THE BLADE "SNAPPED OFF IN PATIENT". THE PHYSICIAN "INITIALLY TRIED TO USE FORCEPS BUT COULD NOT RETRIEVE THE BROKEN PIECE. EVENTUALLY USED SUCTION, WHICH WORKED. NO ADDITIONAL PROCEDURE WAS NEEDED."; THE FRAGMENT WAS SUCCESSFULLY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6561485 ↗