StraightShot 1882040Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 20763000543864), received between Sep 15, 2022 and Sep 16, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Vibration” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Vibration

  It was reported that during Endoscopic septoplasty procedure the blade was rattling. The procedure was completed with replaced device. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785796 ↗
• MalfunctionJan 20, 2026Vibration

  IT WAS REPORTED THAT PREOPERATIVE, WHILE TESTING THE BLADE HEAD WAS SHAKING VERY SEVERELY. HOWEVER, AFTER REPLACING IT WITH ANOTHER NEW BLADE HEAD, THE TEST WAS NORMAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112379 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT PRE-OP, THE DOCTOR TOOK BLADE OUT AND TRIED TO TURN IT A FEW TIMES, BUT IT BROKE DURING THE TESTING. ANOTHER BLADE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343256 ↗
• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, HE FOUND THE BLADE HAS OBVIOUSLY SWUNG. THE DOCTOR TRIED TO REINSTALLED BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO COMPLETE THE SURGERY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281204 ↗
• MalfunctionJan 30, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USAGE, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, FOUND THE BLADE HAD OBVIOUS SHAKE. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT STILL HAD OBVIOUS SHAKE. FINALLY, THE DOCTOR CHANGED A NEW BLADE AND THE NEW BLADE COULD FUNCTION NORMALLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271020 ↗
• MalfunctionJan 29, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USE, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, IT WAS FOUND THAT THE BLADE HAD VISIBLY SWAY. THE DOCTOR TRIED TO RECONNECT THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO PERFORM THE SURGERY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261821 ↗
• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USE, HCP INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING AND FOUND THAT THE BLADE HAD VISIBLY SWAY. HCP TRIED TO RECONNECT THE BLADE BUT USELESS. FINALLY, HCP CHANGED A NEW BLADE TO PERFORM THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250671 ↗
• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT BLADE WAS WOBBLING. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLADE AND THE VIBRATING DEVICE WAS NOT USED ON THE PATIENT. THE DEVICE WAS CHECKED PRIOR TO USE, RESEATED AND WAS STILL WOBBLING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249746 ↗
• MalfunctionJan 22, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT, BEFORE THE PROCEDURE, BLADE CAN NOT ROTATE AND WITH STRANGE NOISE. THE BLADE WAS BROKEN DURING CONTINUING ROTATE AND BROKEN INTO TWO PIECES. THOUGHT IT WAS MICRODEBRIDER¿S HANDPIECE PROBLEM, BUT WHEN REPLACED THE NEW MICRODEBRIDER, BLADE DID NOT MAKE THINGS WELL. AFTER THE CONTINUOUS ATTEMPT, THE CORE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208640 ↗
• MalfunctionMay 21, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-OP, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, HE FOUND THAT THE BLADE HAD OBVIOUSLY SWAY, WOBBLE . THE DOCTOR TRIED TO RECONNECT THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO PERFORM THE SURGERY. THERE WAS NO NOTICEABLE DAMAGE ON THE BLADE OR ITS PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. ONE BLADE HAD ISSUE OUT OF FIVE BLADES IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356823 ↗
• MalfunctionMay 21, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING INTRA-OP, WHEN THE DOCTOR USED THE BLADE AT THE BEGINNING, USED THE BLADE LESS THAN 30 SECONDS AND FOUND BLADE WOBBLING, SWAY. THE DOCTOR TRIED TO RECONNECT THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED TO A NEW BLADE TO COMPLETE THE SURGERY. THERE WAS NO NOTICEABLE DAMAGE ON THE BLADE OR ITS PACKAGE. THERE WAS NO PATIENT IMPACT. ONE BLADE HAD ISSUE OUT OF FIVE BLADES IN THE PACKAGE. THE BLADE WAS NOT CHECKED FOR WOBBLE PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356778 ↗
• MalfunctionMay 10, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BLADE WAS WOBBLING WHILE USING. THE PROCEDURE WAS EXTENDED FOR 3 MINUTES AND COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19290331 ↗
• MalfunctionFeb 27, 2024Vibration; Vibration

  IT WAS REPORTED THAT BLADE STOPPED WORKING DURING THE CASE. IT WAS REPLACED BY THE SAME MODEL WHICH THEN WORKED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT. AS PER ANALYSIS FINDINGS BLADE WAS EXCESSIVE WOBBLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790434 ↗
• MalfunctionFeb 7, 2024Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, WHEN USER INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, THEY FOUND THAT THE BLADE HAD OBVIOUSLY SWAY. THEY TRIED TO RECONNECT THE BLADE BUT USELESS. PROCEDURE WAS COMPLETED THAT ANOTHER BLADE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18657708 ↗
• MalfunctionNov 25, 2023Vibration; Vibration

  IT WAS REPORTED THAT USER CAN CONFIRM THAT CERTAIN 2 MM INFERIOR TURBINATE SHAVERS FROM MEDTRONIC WAS FAULTY. DESPITE THE BLADE BEING SEATED PROPERLY INSIDE THE MICRODEBRIDER HANDLE (CONFIRMED BY SEEING THE JAWS MOVE IN THE DISTAL END), SOME OF THESE BLADES ROCK BACK FORTH AND DO NOT PROVIDE ADEQUATE DEBUNKING OF TISSUE. WHEN USER INSPECT THE BLADE IT¿S UNCLEAR IF ITS BENT, OR SIMPLY NOT COMPATIBLE WITH THE MICRODEBRIDER. AS SOON AS USER SWITCH THE BLADE TO A SIMILAR 2MM MEDTRONIC TURBINATE SHAVE, IT WAS NO LONGER ROCKS TO FRO, AND VISUALLY USER CAN SEE DEBUNKING OF TISSUE. I¿VE HAD TO SWITCH OUT THE TURBINATE BLADES ON AT LEAST 5 SHAVERS THROUGHOUT MY TIME HERE AT MAPLES SURGICAL CENTRE. USER NOW HAVE TO CHANGE MY PRACTICE BY ENSURING THAT THE BLADES DO NOT ROCK DANGEROUSLY WHILE THE SHAVER DEVICE PEDDLE IS TURNED ON, AND USER CONFIRM THIS WITH NURSING OUTSIDE OF THE PATIENT. THERE WAS TEN MINUTES OF SURGERY EXTERNSION. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207647 ↗
• MalfunctionSep 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PRE-OP WHEN THE DOCTOR OPENED THE PACKAGE, HE FOUND THAT THE TIP OF THE INNER BLADE WAS BROKEN AND FRAGMENTS DETACHED FROM THE BLADE. SO, THE DOCTOR CHANGED TO A NEW BLADE. THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17693769 ↗
• MalfunctionMay 24, 2023Vibration; Vibration

  IT WAS REPORTED THAT, DURING R+T PROCEDURE THE BLADE WAS USED FOR ABOUT 5 MINUTES AND FOUND THAT THE BLADE HAD OBVIOUS SHAKE. THE PROCEDURE HAS BEEN COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AS BLADE HAS BEEN CHECKED PRIOR TO USE FOR VIBRATION/WOBBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990326 ↗
• MalfunctionApr 11, 2023Vibration; Vibration

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING THE PROCEDURE, FOUND THAT THE BLADE TIP KEPT SHAKING UP AND DOWN IN AN AB NORMAL AMPLITUDE. INITIALLY THE ROATING SPEED OF THE BLADE SET TO 7500 ROTATIONS, WHICH WAS TOO HIGH, SO IT WAS CHANGED THE SPEED TO 3000 ROTATIONS. BUT AFTER THE CHANGE, THE TIP WAS STILL SHAKING IN AN ABNORMAL AMPLITUDE. THERE WAS NO INTERVENTION PERFORMED AND THE SURGERY WAS COMPLETED WITH BACK UP PRODUCT. ADDITIONAL INFO RECEIVED THAT, DEVICE WAS CHECKED FOR WOBBLE PRIOR TO USE AND THE HCP REPLIED THAT THE VIBRATION OF THE ATTACHMENT WAS NORMAL DURING THE BEGINNING OF OPERATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714262 ↗
• MalfunctionDec 21, 2022Break; Break

  A HEALTHCARE PROVIDER REPORTED THAT DURING SMT PROCEDURE, WHEN DOCTOR USED THE BLADE FOR ABOUT 5 MINUTES, THE BLADE BROKE FROM THE TIP. SO, THEY CHANGED A NEW BLADE TO COMPLETE THE SURGERY. THERE WAS 3 MINUTES DELAY IN THE PROCEDURE. THERE WAS NO BROKEN PIECES REMAINS INSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT. THE BLADE WAS BROKEN WHILE BEING USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16021502 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT DURING PRE-OP, THE INNER TUBE OF THE SHAVER WAS BROKEN INTO 2 PARTS WHILE TESTING THE SHAVER, AT THEN IT'S CONFIRMED THAT THE SHAVER WAS WELL INSTALLED WITHOUT SHAKING. AFTER CHANGING TO NEW SHAVER THE ISSUE IS GONE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED, THE BLADE DID NOT BROKE WHILE INSERTING OR REMOVING FROM THE HANDPIECE. THE SHAVER COULD NOT EVEN INSTALLED ONTO THE HANDPIECE THAT IT WAS NOT RUNNING WITH ANY SPEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428146 ↗