Stealthstation® S7™ 9733856Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,908 adverse event reports that list this exact device (DI 00613994450944), received between Sep 19, 2016 and Dec 4, 2025 — classified as 6 deaths, 231 injuries, 3,671 malfunctions.

The most frequently reported specific device problem is “Imprecision” (824 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 25 most recent of 3,908 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD AN ALLEGED INACCURACY AFTER TWO SPINS OF THE IMAGING SYSTEM. THE MEDTRONIC REPRESENTATIVE (REP) NOTED THE FRAME DID NOT MOVE. THE LENGTH OF DELAY IN THE PROCEDURE AND PATIENT IMPACT ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716222 ↗
• MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS AN INACCURACY ON ALL INSTRUMENTS AS ALL WERE BEING USED. A DIFFERENT NAVIGATION SYSTEM WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464885 ↗
• MalfunctionSep 12, 2025Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch; Unintended Application Program Shut Down; Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch; Unintended Application Program Shut Down

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING SURGERY WHILE IN NAVIGATION, THE SYSTEM DISPLAYED A MESSAGE THAT IT WAS EXITING SOFTWARE AND BECAME UNRESPONSIVE. THE REPRESENTATIVE REBOOTED SYSTEM AND WAS ABLE TO PROCEED WITH CASE. LATER DURING THE SAME SURGERY, THE SYSTEM DISPLAYED NO SIGNAL ON THE DISPLAY WHILE IN NAVIGATION. THE REPRESENTATIVE REBOOTED SYSTEM AGAIN AND COMPLETED CASE WITHOUT FURTHER ISSUE. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039343 ↗
• MalfunctionSep 11, 2025Communication or Transmission Problem; Device Sensing Problem; Communication or Transmission Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM SHOWED ARTIFACT IN IMAGES TRANSFERRED FROM AN IMAGING ACQUISITION SYSTEM (IAS) SPIN DURING A SPINE CASE. INITIALLY THE NAVIGATION SYSTEM'S NETWORK PORT WAS REPORTEDLY "PUSHED IN", PREVENTING THE NETWORK CABLE FROM CONNECTING THE SYSTEM TO THE IAS. AFTER THE CONNECTION WAS FINALLY ESTABLISHED, THE SPIN PROCEEDED. THE IMAGES ON THE MOBILE VIEWING STATION (MVS) REPORTEDLY DO NOT HAVE ARTIFACT, BUT THE IMAGES TRANSFERRED TO THE NAVIGATION SYSTEM DID. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028527 ↗
• MalfunctionJul 9, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM HAD AN ISSUE THAT IT CAN¿T RECEIVE THE IMAGE AND NO ERROR OCCURRED AFTER IMAGING SYSTEM IMAGE TRANSFERRED. NAVIGATION WAS DISCONTINUED. THIS ISSUE CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460961 ↗
• MalfunctionJun 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE SETTING THE SYSTEM UP THIS MORNING, HE WAS DOWNLOADING IMAGES FROM DICOM AND WOULD GO INTO THE SPINE SOFTWARE, BUT THE SYSTEM WOULD SHOW NO IMAGES AVAILABLE FOR THE PATIENT. AFTER 3 SYSTEM RESTARTS, THE IMAGES APPEARED AND THE ISSUE WAS RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22238065 ↗
• MalfunctionMay 22, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE FLOURONAV WAS SHORTING OUT. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. NAVIGATION WAS ABORTED. THERE WAS A REPORTED DELAY OF LESS THAN 1 HOUR AND NO REPORTED IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT THEY WERE UNABLE TO GET IMAGES SENT TO THE NAVIGATION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071315 ↗
• MalfunctionMar 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INACCURACY WAS 1-2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735686 ↗
• MalfunctionMar 28, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S SIDE EMITTER WAS MALFUNCTIONING AND REQUIRED REPLACEMENT. IT WAS NOTED THAT THERE WAS A CRACK IN THE EMITTER. IT WAS FUNCTIONAL RECENTLY DESPITE THE CRACK, AND HAD BEEN USED SUCCESSFULLY UNTIL THE DAY OF THE COMPLAINT WHEN THE SITE CALLED TO REPORT IT WAS NO LONGER WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720688 ↗
• MalfunctionMar 27, 2025Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM BOOTED WITH A "NO SIGNAL" MESSAGE AND A BLACK SCREEN. TO RESOLVE THE ISSUE, THE MEDTRONIC REPRESENTATIVE HAD TO REMOVE THE BACK PANEL AND RESTART THE COMPUTER MANUALLY UNTIL THE BATTERY/FAN INITIATED A HARD REBOOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712957 ↗
• MalfunctionMar 19, 2025Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY IN A CRANIAL RESECTION. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS END-OF-LIFE. AN INACCURACY OCCURRED, THE ELECTRO MAGNETIC FIELD WAS VERY SMALL AND UNSTABLE DUE TO THE EMITTER IN ALL DIRECTIONS. TRACER REGISTRATION WAS USED AND THE INACCURACY OCCURRED DURING THE PATIENT REGISTRATION. A NON-INVASIVE PATIENT TRACKER WAS USED IN RELATION TO THE EMITTER ON THE FOREHEAD. THE SITE HAD TO USE ANOTHER DEPARTMENT'S NAVIGATION SYSTEM TO COMPLETE THE PROCEDURE. NO KNOWN IMPACT TO PATIENT OUTCOME. THERE WAS A SURGICAL DELAY OF ONE HOUR OR LONGER AND THE NAVIGATION SYSTEM WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642861 ↗
• MalfunctionMar 13, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING NO SIGNAL. THERE WAS NO SIGNAL ON BOTH MONITORS AND IT WAS CONFIRMED THAT THE COMPUTER WAS RECEIVING POWER BY OPENING DISC DRIVE. THE CPU WAS FAILING. THERE WAS NO PATIENT INVOLVEMENT. THE CAMERA WAS CYCLING. THE SITE RAN REV14 AND THE ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594981 ↗
• MalfunctionMar 4, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SPHERES WOULD FLICKER IN AND OUT OF THE TRACKING WINDOW DURING THE CASE. IT WAS NOTED THAT THE INSTRUMENTS VERIFIED WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518534 ↗
• MalfunctionFeb 21, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO TRACK THE PATIENT TRACKER. THE SITE SWITCHED NAVIGATION SYSTEMS, AND THE SYSTEM BEGAN FUNCTIONING AS INTENDED. THIS OCCURRED INTRAOPERATIVELY, AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. THE TYPE OF PROCEDURE WAS UNKNOWN. THERE WAS A DELAY TO THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THAT DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437792 ↗
• MalfunctionFeb 21, 2025Mechanical Problem; Application Program Problem; Connection Problem; Mechanical Problem; Application Program Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LOCALIZER WAS NOT CONNECTED. THE CAMERA WAS INTERMITTENTLY WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433748 ↗
• MalfunctionFeb 13, 2025Display or Visual Feedback Problem; Device Sensing Problem; Display or Visual Feedback Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT ABLE TO BOOT UP. THEY TURNED THE SYSTEM ON AND THE STAFF CART DISPLAYED 'NO SIGNAL' AND THE SURGEON CART MONITOR APPEARED TO BE OFF. THEY CONFIRMED THE SURGEON MONITOR WAS PLUGGED IN AND THE SYSTEM WAS PLUGGED INTO ITS OWN OUTLET. THEY TRIED TO REBOOT THE SYSTEM WITH NO CHANGE. THE DISC DRIVE WAS UNABLE TO OPEN, BUT THEY COULD NOT TELL IF THE FANS WERE RUNNING ON THE SYSTEM OR NOT. THEY ALSO STATED THAT THEY DON'T THINK THE SYSTEM HAD BEEN LEFT PLUGGED IN WHEN NOT IN USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376323 ↗
• MalfunctionFeb 13, 2025Application Program Problem; Device Sensing Problem; Application Program Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED NO SIGNAL. A MANUFACTURING REPRESENTATIVE (REP) ASSISTED WITH WALKING THROUGH RESETTING CMOS WHICH RESOLVED THE ISSUE. THERE WAS A LESS THAN HOUR SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376138 ↗
• MalfunctionFeb 13, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE CAMERA COULD NOT SEE THE IMAGING SYSTEM OR TRACKERS. THE SYSTEM WAS REBOOTED AND ALL ISSUES WERE RESOLVED. THE REPRESENTATIVE CHECKED THE SYSTEM POST OP AND IT FUNCTIONED AS DESIGNED. THERE WAS NO SURGICAL DELAY AND NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374478 ↗
• MalfunctionFeb 7, 2025Device Sensing Problem; Adverse Event Without Identified Device or Use Problem; Device Sensing Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT SEEING THE IMAGING SYSTEM TRACKERS. THE MEDTRONIC REPRESENTATIVE ADDED THE IMAGING SYSTEM INTO THE PROCEDURE AND IT WAS RESOLVED. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333655 ↗
• MalfunctionFeb 7, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT SEEING THE IMAGING SYSTEM TACKERS. THE MEDTRONIC REPRESENTATIVE ADDED THE IMAGING SYSTEM INTO THE PROCEDURE AND IT WAS RESOLVED. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333606 ↗
• MalfunctionJan 31, 2025Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch; Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON TRYING TO SELECT A PROCEDURE, THE NAVIGATION SYSTEM DISPLAYED "ERROR SETTING UP TASK FLOW. PLEASE ENSURE SYSTEM HAS PROPER TASK FLOW FILE". THERE WAS NO PATIENT INVOLVED. TROUBLESHOOTING WAS DONE THROUGH MULTIPLE REBOOTS AND TRYING TO SELECT DIFFERENT PROCEDURES AND DIFFERENT SURGEON PROFILES BUT THE ISSUE STILL PERSISTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURER REPRESENTATIVE WAS ABLE TO SUCCESSFULLY REINSTALL SPINE AND TRAUMA SOFTWARE APPLICATION. THE ISSUE WAS THEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287066 ↗
• MalfunctionJan 21, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON BOOTUP, THE SYSTEM MONITOR DISPLAYED A BLUE SCREEN. THE BLUE SCREEN PERSISTED FOR ABOUT 5 MINUTES, BEFORE SHOWING THE LOG IN SCREEN. TROUBLESHOOTING STEPS WERE PERFORMED AT THE TIME OF CALL. THE MANUFACTURER REPRESENTATIVE WAS IN FRONT OF THE SYSTEM AND COULD NOT GET THE ISSUE TO REPLICATE. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE RESTARTED THE SYSTEM MULTIPLE TIMES, AND THE ISSUE DID NOT OCCUR. THEY ALSO WENT TO THE REGISTRATION PAGE, AND THE ISSUE STILL DID NOT OCCUR. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200344 ↗
• MalfunctionJan 21, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN ATTEMPTING TO PULL AN IMAGE FROM THE PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (PACS), THE IMAGE DOWNLOADED ROUGHLY 80% OF THE WAY BEFORE DISPLAYING AN ERROR MESSAGE THAT READ "TRANSFER INCOMPLETE, PLEASE TRY AGAIN LATER." THE SITE HIT ¿OK¿ TO ACKNOWLEDGE THE ERROR. THE SITE NOTED THAT WHEN VIEWING THE PATIENT EXAM, IT DOWNLOADED ALL THE WAY, WITH NO SLICES MISSING. TROUBLESHOOTING STEPS WERE PERFORMED AT THE TIME OF CALL. THE MANUFACTURER REPRESENTATIVE WAS IN FRONT OF THE SYSTEM AND COULD NOT GET THE ISSUE TO REPLICATE. THEY PULLED SEVERAL OTHER IMAGES THAT ALL TRANSFERRED WITHOUT ISSUE AND WITHOUT AN ERROR MESSAGE. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE ALSO ATTEMPTED TO PULL ON A DIFFERENT PACS PORT, BUT AGAIN, THE ISSUE COULD NOT BE REPLICATED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200021 ↗
• MalfunctionJan 16, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT ABLE TO RETRIEVE IMAGES FROM FACILITY PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS) NETWORK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170548 ↗
• MalfunctionJan 10, 2025No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY. THE SURGEON STARTED A TRACE REGISTRATION BUT NOTICED THE STARTING POINT WHICH SHOULD BE ON THE NOSE WAS APPEARING VIRTUALLY ON THE PATIENT'S NECK. THE REPRESENTATIVE STATED THE PATIENT'S AXIAL VIEW WAS LABELED AS A CORONAL VIEW, AND VICE VERSA. THE SURGEON WAS UNABLE TO REGISTER THE PATIENT AND ENDED UP ABORTING NAVIGATION. THE ISSUE TOOK PLACE DURING REGISTRATION. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED DURING THE CALL BUT THE SURGEON DID TRY MANUALLY MOVING THE NOSE POINT BUT THE NEW POINT WAS OFF BY SEVERAL INCHES. THERE WAS A REPORTED DELAY OF LESS THAN 1 HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME. LATER ON, A REPRESENTATIVE WAS ABLE TO COMPLETE A REGISTRATION USING A RESIN HEAD DUMMY MODEL AND EXAM WITH NO ISSUES. TECHNICAL SERVICES (TS) REPORTED THE LIKELY ISSUE BEING DUE TO USER ERROR, POSSIBLY FROM POOR OR MISLABELED EXAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125262 ↗