Fusion® 1884006EMRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994617408), received between Jul 30, 2018 and Aug 7, 2020 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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.

• MalfunctionAug 7, 2020Break; Break

  IT WAS REPORTED VIA HEALTH CARE PROFESSIONAL THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE BLADE'S TIP BROKE INTO A SMALL PIECE. THERE WAS NO BROKEN PIECE OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) WITH NO DELAY. THERE WAS NO INTERVENTION PERFORMED/PLANNED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381593 ↗
• MalfunctionMar 16, 2020Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE FUSION BLADE BROKE DURING THE MIDDLE OF THE CASE. THERE WERE FRAGMENTS. THERE WAS NO PATIENT INJURY AND NO DELAYED TIME IN THE CASE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9834270 ↗
• MalfunctionFeb 13, 2020Break; Break

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT A DEVICE BLADE CAME APART WHEN SEEDING IN HANDPIECE DURING SINUS SURGERY PROCEDURE. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9705581 ↗
• MalfunctionMay 17, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE BLADE BROKE IN HALF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619948 ↗
• InjuryApr 22, 2019Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow

  A HEALTH CARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, A BLADE KEPT GETTING CLOGGED AND WAS CLEARED MULTIPLE TIMES WITH A STYLET. THE SURGEON REMOVED TIP AND INSERTED STYLET FROM HIND END TO CLEAR BLADE. THE BLADE WAS REPLACED ON THE HANDPIECE AND USED IN THE RIGHT NASAL CAVITY. BLADE STOPPED WORKING AND UPON REMOVAL IT WAS NOTICED THAT THE TIP WAS MISSING AND A SPRING WAS SHOWING. THE SURGEON USED A 30 DEGREE SCOPE TO LOCATE THE BLADE TIP COVER IN THE CAVITY. AN X-RAY CONFIRMED ABSENCE OF ANY FOREIGN BODIES. THERE WAS A DELAY IN THE SURGICAL PROCEDURE OF LESS THAN 1 HOUR.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8537494 ↗
• MalfunctionMar 20, 2019Material Separation; Material Separation

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE BROKE OFF DURING THE PROCEDURE. THERE WERE NO FRAGMENTS THAT FELL ON THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE AS ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436537 ↗
• MalfunctionNov 30, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE INNER BLADE WAS COMPLETELY BUSTED INSIDE OF THE OUTER BLADE. THROUGH FOLLOW-UP REQUEST, IT WAS REPORTED THAT THE INNER BLADE WAS BROKEN AND DETACHED FROM THE OUTER BLADE DURING A FUNCTIONAL ENDOSCOPIC SURGERY (FESS) PROCEDURE. A NEW BLADE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8119390 ↗
• MalfunctionNov 30, 2018Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE INNER BLADE FELL OFF DURING THE PROCEDURE. THE DEVICE WAS USED IN AN OSCULATING MANNER. IT WAS THE FIRST TIME THE BLADE WAS USED. THE CASE WAS COMPLETED USING A DIFFERENT BLADE. THERE WAS A DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8119292 ↗
• MalfunctionNov 2, 2018Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE WAS BROKEN INTO PIECES DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. A BACKUP DEVICE WAS NOT USED BECAUSE THE PROCEDURE WAS ALMOST COMPLETED HOWEVER, THERE WAS A 30-MINUTE DELAY DUE TO THIS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032467 ↗
• MalfunctionJul 30, 2018Break; Difficult to Insert; Material Separation; Difficult to Insert; Material Separation

  ADDITIONAL INFORMATION RECEIVE FROM HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE MENTIONED THAT THE BLADE WAS USED FOR FESS+IGS. THERE WAS NO DELAY IN THE CASE. THE CASE WAS COMPLETED AS THE BLADE WAS NO LONGER REQUIRED, AND THE BLADE HUB WAS REMOVED EASILY FROM THE HANDPIECE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7730503 ↗