SafeOp AIX11901Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00190376330723), received between May 21, 2022 and Feb 20, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Provides Uninformative Message” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Device Provides Uninformative Message

  DURING A SPINAL PROCEDURE USING INTRAOPERATIVE NEUROMONITORING, IT WAS REPORTED THAT THE SYSTEM DISPLAYED AN ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406032 ↗
• MalfunctionJan 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Device Provides Uninformative Message

  DURING A SPINAL PROCEDURE USING INTRAOPERATIVE NEUROMONITORING, IT WAS REPORTED THAT THE SYSTEM DISPLAYED AN ERROR MESSAGE AND EXPERIENCED A FAILED TRIGGERED EMG. THE SCREW TESTING COULD NOT BE COMPLETED, BUT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059635 ↗
• InjuryJan 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  DURING A SPINAL PROCEDURE USING INTRAOPERATIVE NEUROMONITORING, MULTIPLE ELECTRODE CHECKS WOULD NOT PASS THE IMPEDANCE TEST. THE HARNESS AND INDIVIDUAL ELECTRODES WERE REPLACED WITH NO RESOLUTION. THE PATIENT WAS ALREADY UNDER ANESTHESIA. THE SURGEON ELECTED TO ABORT THE CASE PRIOR TO INCISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23978131 ↗
• InjuryDec 15, 2025Device Provides Uninformative Message; Device Provides Uninformative Message

  THE SYSTEM DISPLAYED AN ERROR MESSAGE AFTER PATIENT POSITIONING AND SKIN MARKING, BUT PRIOR TO SKIN INCISION. BASELINE RECORDINGS HAD ALREADY BEEN SUCCESSFULLY OBTAINED PRIOR TO THE ALERT. TROUBLESHOOTING WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE. THE SURGEON ELECTED TO CANCEL THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810981 ↗
• MalfunctionJan 13, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED DURING A CASE, THE STANDARD NEEDLE SET UP WAS COMPLETED. WHEN THE LEADS WERE PLUGGED INTO THE UNIT, THE GROUND ELECTRODE WAS NOT REGISTERING IN THE ELECTRODE TEST. THE NEEDLE AND HARNESS WERE REPLACED WITH NO CHANGE. ANOTHER UNIT WAS USED TO COMPLETE THE CASE. THIS RESULTED IN A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509535 ↗
• MalfunctionMar 18, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED DURING SURGERY, THE UNIT GAVE A "CHECK PROBE" ERROR MESSAGE SEVERAL TIMES. MULTIPLE ATTEMPTS WERE MADE TO RESOLVE THE ERROR MESSAGE. THIS RESULTED IN A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569447 ↗
• MalfunctionNov 23, 2022Low Readings; Low Readings

  IT WAS REPORTED DURING A CASE INVOLVING A SAFEOP UNIT LOW TEMG THRESHOLDS OCCURRED ACROSS MULTIPLE SURGICAL LEVELS. THE SURGEON ABORTED THE CASE. IT IS UNKNOWN IF THE LOW VALUES WERE ARTIFACT. THE SALES REP IS CONFIDENT THE BOVIE PAD WASN'T NEAR LEADS AND THAT STIM RETURN AS WELL AS GROUND WERE IN CORRECT LOCATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852591 ↗
• MalfunctionNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A SINGLE LEVEL L4-L5 LIF PROCEDURE WHICH INVOLVED A SAFEOP UNIT. AFTER THE EMG ELECTRODES WERE CONNECTED THERE WAS SPONTANEOUS STIMULATING TO THE PATIENT WITHOUT ANY TRIGGERED EMG BEING ACTIVATED. THE HEADBOX TO THE UNIT WAS TURNED ON AND OFF MULTIPLE TIMES. THERE WAS A RHYTHMIC TWITCH IN THE PATIENT'S FOOT WHEN THE MACHINE WAS ON, BUT WITHOUT THE INPUT OF ANY TRIGGERED EMG OR SSEP STIMULUS. THIS SAME TWITCH WAS NOT PRESENT WHEN THE HEADBOX POWER WAS TURNED OFF. THE SURGEON ABORTED THE CASE DUE TO THIS INCIDENT.

  Patient problems: Twitching

  MAUDE report 15810419 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A PATIENT HAD A POSTOPERATIVE DEFICIT AFTER UNDERGOING A SPINAL PROCEDURE WHERE A SAFEOP UNIT WAS USED. IT WAS REPORTED THE PATIENT HAD QUADRICEPS WEAKNESS ON THE OPERATIVE SIDE. THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 14465333 ↗