Fusion® 1884080EMRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00613994617422), received between Jan 23, 2017 and Sep 18, 2023 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Material Separation” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2023Break; Break

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, WHEN THE DOCTOR USED THE BLADE FOR ABOUT 15 MINUTES, THE TIP OF THE INNER BLADE WAS BROKEN. FRAGMENTS FORMED FROM THE DEVICE BUT WERE CONTAINED IN THE OUTER SHAFT. SO, THE DOCTOR CHANGED TO A NEW BLADE TO COMPLETE THE SURGERY. PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763315 ↗
• MalfunctionMar 15, 2022Vibration; Material Twisted/Bent; Noise, Audible; Vibration; Material Twisted/Bent; Noise, Audible

  A HEALTH CARE PROVIDER(HCP) REPORTED VIA CALL THAT SCHAEFER SOUNDED FUNNY, WASN¿T MAKING THIS SOUND IT WAS SUPPOSED TO. THE BLADE STARTED TO WOBBLE, MEDTRONIC SALES REPRESENTATIVE TOLD THE HCP TO DISCONTINUE USE AND OPEN UP A ANOTHER BLADE. SECOND PLATE WAS USED CASE WAS FINISHED WITH NO INCIDENT. HCP ALSO MENTIONED THAT HE WAS USING THE PRODUCT IN THE APPROPRIATE MANNER. HE HIT SOME HARD BONES WITH THE SHAVER AND BENT THE TINES. THERE WAS NO INTERVENTION PLANNED/PERFORMED. THERE WAS NO PROCEDURE DELAY AND PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT. ON FOLLOW UP IT WAS MENTIONED THAT DR. HILTON SAID THE BLADE WAS WOBBLING AND NOT SOUNDING QUITE RIGHT, THEN HE ADDED I DID GO THROUGH SOME HARD BONE. THE ISSUE WAS FOUND WHILE USING ON THE PATIENT. MEDTRONIC SALES REP TOLD HIM TO DISCONTINUE USE AND OPEN ANOTHER BLADE. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE: BLADE WAS TESTED FOR WOBBLE PRIOR USING ON THE PATIENT. BLADE WORKED AS EXPECTED FOR THE FIRST HALF OF THE CASE AND THEN AS HCP WAS WORKING INTO THE POSTERIOR ETHMOID SPACE OF THE PATIENT¿S LEFT SIDE. HCP WAS WORKING ON A BONY PARTITION AND THEN THE BLADE BEGAN TO WOBBLE. HCP THEN RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13768072 ↗
• MalfunctionAug 9, 2019Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT A BLADE TIP WAS BROKEN WHEN IT WAS TAKEN OUT FROM PACKAGING. IT WAS DISCOVERED DURING THE PROCEDURE BEFORE USING ON THE PATIENT'S BODY. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879012 ↗
• MalfunctionJul 31, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) CASE WHEN THE SURGEON BEGAN TO USE THE BLADE THE TIP BROKE OFF AND FELL ONTO THE FLOOR. THE SITE OPENED A NEW BLADE AND CONTINUED THE CASE. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8845910 ↗
• MalfunctionJun 24, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE BROKE APART WHILE BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) IN REMOVING POLYPS. THEY OPENED A NEW BLADE AND CONTINUED WITH THE PROCEDURE. THE DEVICE WAS NOT REPROCESSED AND WAS USED FOR THE FIRST TIME. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8726530 ↗
• MalfunctionJun 5, 2019Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE POPPED OFF DURING A SINUS SURGERY. THE DEVICE WAS REPLACED WITH ANOTHER BLADE FROM THE SAME BATCH AND IT POPPED OFF AS WELL. THE FIRST ONE WAS USED ON PATIENT BUT THE SECOND ONE WAS NOT. IT WAS NOTED THAT THERE WAS NO BROKEN PIECES LEFT INSIDE THE PATIENT'S BODY. THERE WAS NO INTERVENTION PLANNED OR PERFORMED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670439 ↗
• MalfunctionJun 5, 2019Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE POPPED OFF DURING A SINUS SURGERY. THE DEVICE WAS REPLACED WITH ANOTHER BLADE FROM THE SAME BATCH AND IT POPPED OFF AS WELL. THE FIRST ONE WAS USED ON PATIENT BUT THE SECOND ONE WAS NOT. IT WAS NOTED THAT THERE WAS NO BROKEN PIECES LEFT INSIDE THE PATIENT'S BODY. THERE WAS NO INTERVENTION PLANNED OR PERFORMED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670312 ↗
• MalfunctionFeb 25, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SHAVER CAME APART. UPON FOLLOW-UP IT WAS CONFIRMED THAT THE EVENT OCCURRED INTRAOPERATIVELY. THE CASE WAS COMPLETED USING A NEW BLADE. THERE WERE NO FRAGMENTS OF THE BLADE LEFT IN THE PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8368155 ↗
• MalfunctionJan 23, 2019Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT WHILE USING THE SHAVER, THE TIP BROKE OFF. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270153 ↗
• MalfunctionJan 15, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE BROKE OFF WHEN IN USE. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS 5 MINUTES DELAY WHILE THEY OPENED ANOTHER BLADE TO USE. THE BROKEN PIECES OF THE BLADE WERE RETRIEVED OUT OF THE PATIENT. THERE WAS NO PATIENT OR EMPLOYEE IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249886 ↗
• MalfunctionJan 8, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE BLADE FELL APART AS SOON AS REMOVED FROM THE PACKAGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8226472 ↗
• MalfunctionDec 3, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT A BLADE FELL APART, PRE-OPERATIVELY. THERE WAS NO PATIENT IMPACT. ON FOLLOW UP, IT WAS CONFIRMED THAT THE BLADE FELL APART WHEN THEY OPENED THE PACKAGING, A NEW BLADE WAS PROVIDED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124458 ↗
• MalfunctionNov 26, 2018Unstable; Unstable

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE BLADE WAS WOBBLING IN THE HANDPIECE WHEN OPERATING DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THE BLADE WAS REMOVED AND REINSERTED BUT THAT DID NOT SOLVE THE ISSUE. ANOTHER BLADE WAS OPENED TO FINISH THE CASE. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102636 ↗
• MalfunctionNov 21, 2018Material Separation; Material Separation

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE BROKE OFF DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. THE BROKEN PIECE WAS REMOVED FROM THE SINUS CAVITY. THE PROCEDURE WAS DELAYED FOR 5 MINUTES AS A NEW BLADE WAS USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8094678 ↗
• MalfunctionNov 20, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE BROKE INTO 2 PIECES DURING A SEPTOPLASTY SURGERY. THE HCP WAS ABLE TO RETRIEVE THE BROKEN PIECE. THE HCP NOTED THAT THIS WAS THE INITIAL USE OF THE DEVICE. THERE WAS NO MAJOR DELAY IN THE PROCEDURE AND THE CASE WAS COMPLETED USING A NEW BLADE. THERE WERE NO NON-ROUTINE ACTIONS TAKEN TO PREVENT IMPACT OR INJURY IN ASSOCIATION WITH THIS DEVICE. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8090021 ↗
• MalfunctionNov 12, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE BLADE BROKE OFF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061182 ↗
• MalfunctionNov 5, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE A NEW BLADE BROKE OFF IN THE NASOPHARYNX OF THE PATIENT DURING A SINUS SURGERY. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE AND A BACK UP DEVICE WAS USED. THERE WAS NO PATIENT IMPACT ALTHOUGH THE SURGEON DID HAVE TO RETRIEVE BROKEN PIECE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038282 ↗
• MalfunctionNov 1, 2018Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE WAS NOT OPERATING CORRECTLY DURING THE ETHMOIDECTOMY PROCEDURE. THE BLADE WAS REVERBERATING BACK AND FORTH. THE FOOT PEDAL WAS CHECKED AND TESTED DIFFERENT GENERATOR, ALL APPEARED WELL. THIS WAS THE FIRST TIME THAT THE DEVICE WAS USED. A BACK UP PRODUCT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS A 10 MINUTE DELAY DUE TO TROUBLE SHOOTING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8030164 ↗
• MalfunctionOct 30, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE METAL PORTION INSIDE THE BLADE, THAT CONNECTS TO THE HANDPIECE BROKE OFF. THE PLASTIC AND METAL BROKE OFF WHILE BEING USED IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8018360 ↗
• MalfunctionOct 22, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT A BLADE'S PLASTIC PORTION BROKE OFF DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7992095 ↗
• MalfunctionOct 12, 2018Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE TOP PART OF THE BLADE FELL OFF INTO THE PATIENT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE. THE BROKEN PIECE WAS RETRIEVED AND ANOTHER BLADE WAS USED TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962873 ↗
• MalfunctionOct 8, 2018Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow

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

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7945151 ↗
• MalfunctionSep 26, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT DURING A TRANSSPHENOIDAL SURGERY, THE INNER CUTTING CANNULA FRACTURED OFF. THIS HAPPENED WITH TWO DIFFERENT BLADES USING THE SAME HANDPIECE. AFTER THE SECOND BLADE FRACTURED, THE HANDPIECE WAS SWITCHED AS THE HCP THOUGHT THE HANDPIECE WAS CAUSING THE ISSUE; HOWEVER, A THIRD BLADE FRACTURED. ALL PARTS THREE PIECES OF THE BLADES WERE REMOVED FROM THE PATIENT USING A PICKUP INSTRUMENT WITH NO ISSUE. THE POWER CONSOLE WAS SET AT 5K AND ON OSCILLATING MOVEMENT. THE PROCEDURE WAS DELAYED APPROXIMATELY 25 MINUTES DUE TO SWITCHING THE BLADES AND HANDPIECE. THE CASE WAS COMPLETED USING A DIFFERENT BLADE. NO FURTHER ACTIONS WAS TAKEN. THERE WAS NO PATIENT IMPACT. REFER TO MANUFACTURER REPORT # 1045254-2018-00467 AND 1045254-2018-00468.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7910127 ↗
• MalfunctionSep 26, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT DURING A TRANSSPHENOIDAL SURGERY, THE INNER CUTTING CANNULA FRACTURED OFF. THIS HAPPENED WITH TWO DIFFERENT BLADES USING THE SAME HANDPIECE. AFTER THE SECOND BLADE FRACTURED, THE HANDPIECE WAS SWITCHED AS THE HCP THOUGHT THE HANDPIECE WAS CAUSING THE ISSUE; HOWEVER, A THIRD BLADE FRACTURED. ALL PARTS THREE PIECES OF THE BLADES WERE REMOVED FROM THE PATIENT USING A PICKUP INSTRUMENT WITH NO ISSUE. THE POWER CONSOLE WAS SET AT 5K AND ON OSCILLATING MOVEMENT. THE PROCEDURE WAS DELAYED APPROXIMATELY 25 MINUTES DUE TO SWITCHING THE BLADES AND HANDPIECE. THE CASE WAS COMPLETED USING A DIFFERENT BLADE. NO FURTHER ACTIONS WAS TAKEN. THERE WAS NO PATIENT IMPACT. REFER TO MANUFACTURER REPORT # 1045254-2018-00467.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7909942 ↗
• MalfunctionSep 26, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT DURING A TRANSPHENOIDAL SURGERY, THE INNER CUTTING CANNULA FRACTURED OFF. THIS HAPPENED WITH TWO DIFFERENT BLADES USING THE SAME HANDPIECE. AFTER THE SECOND BLADE FRACTURED, THE HANDPIECE WAS SWITCHED AS THE HCP THOUGHT THE HANDPIECE WAS CAUSING THE ISSUE; HOWEVER, A THIRD BLADE FRACTURED. ALL PARTS THREE PIECES OF THE BLADES WERE REMOVED FROM THE PATIENT USING A PICKUP INSTRUMENT WITH NO ISSUE. THE POWER CONSOLE WAS SET AT 5K AND ON OSCILLATING MOVEMENT. THE PROCEDURE WAS DELAYED APPROXIMATELY 25 MINUTES DUE TO SWITCHING THE BLADES AND HANDPIECE. THE CASE WAS COMPLETED USING A DIFFERENT BLADE. NO FURTHER ACTIONS WAS TAKEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7909889 ↗