NA DAQ916 (UDI 00643169378476)Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00643169378476), received between Jan 20, 2017 and Jun 18, 2026 — classified as 80 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (47 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-OP, THE NIM ECLIPSE 21 TO 25 PIN IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547397 ↗
• MalfunctionJun 17, 2026Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION, NIM ECLIPSE WAS NOT WORKING PROPERLY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529604 ↗
• MalfunctionMay 26, 2026Use of Device Problem

  IT WAS REPORTED THAT PRE-OP, THE DEVICE WAS NOT WORKING PROPERLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277281 ↗
• MalfunctionMay 20, 2026Use of Device Problem

  IT WAS REPORTED THAT PRE OP THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227245 ↗
• MalfunctionMar 16, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT PREOPERATIVELY DEVICE HAD MULTIPLE CHANNEL PORT RECOGNITION ISSUES AND NOISE OCCURRENCE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602379 ↗
• MalfunctionMar 3, 2026Use of Device Problem

  IT WAS REPORTED THAT BEFORE THE OPERATION, THE PREAMPLIFIER NOT WORKING PROPERLY. THE PROCEDURE WAS COMPLETED WITH THE BACK-UP PRODUCT. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492822 ↗
• MalfunctionJan 23, 2026Device Sensing Problem

  IT WAS REPORTED THAT PRE-OP, THE PREAMPLIFIER WAS NOT COMMUNICATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161360 ↗
• MalfunctionDec 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, NIM PREAMPLIFIER GREEN LIGHT NOT SHOWING AND NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861593 ↗
• MalfunctionDec 8, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION THE PREAMPLIFIER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743519 ↗
• MalfunctionDec 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DEVICE WAS DEFECTIVE AND SENT FOR TESTING. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703487 ↗
• MalfunctionDec 2, 2025Use of Device Problem; Connection Problem; Use of Device Problem; Connection Problem

  IT WAS REPORTED THAT PRE-OP, THE PREAMPLIFIER WAS NOT WORKING AND HAD CONNECTING ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692270 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRE-OP, THE ENTIRE NIM SETUP DOES NOT WORK. INITIALLY THERE WAS A PROBLEM WITH THE CABLE FROM THE STIMULATOR EX TENDER, IT HAD DAMAGED PINS AND THE STIMULATOR WAS NOT WORKING. THE CABLE WAS REPLACED TOGETHER WITH ANOTHER STIMULATION BOX BUT THE STIMULATOR STILL DID NOT WORK. AND ON THE NIM SCREEN THE ERROR APPEARED: ELECTRO STIMULATOR MODULE FAILURE: 0X00-ST. THERE WAS NO P ATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566387 ↗
• MalfunctionNov 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING START OF A CASE, USER TRIED TO SETUP NIM ECLIPSE BUT IT DID NOT WORK SO WHILE CONNECTING THE NEEDLES INTO THE PATIENT, USER RESTARTED THE COMPUTER TO SEE IF IT WOULD WORK AND IT DID NOT WORK. THERE WAS A CONSTANT ERROR ON THE SCREEN SAYING ¿SELF-TEST INDICATES A OUTPUT FAILURE. AS WELL AS SAYING MULTIPLE INSTANCES DETECTED, STIMULATION MODE AND THE WHOLE COMPUTER WOULD SHUT DOWN THERE AFTER THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507812 ↗
• MalfunctionNov 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT NIM ECLIPSE WAS FAULTY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507762 ↗
• MalfunctionOct 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE NIM ECLIPSE PREAMPLIFIER NOT WORKING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376585 ↗
• MalfunctionOct 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRE OP, THE NIM ECLIPSE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355100 ↗
• MalfunctionOct 15, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS SENT FOR PREVENTIVE MAINTAINANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276257 ↗
• MalfunctionAug 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION, THE PREAMPLIFIER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881733 ↗
• MalfunctionJul 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION NIM ECLIPSE SYSTEMS WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540663 ↗
• MalfunctionJul 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION NIM ECLIPSE SYSTEMS WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540599 ↗
• MalfunctionJul 7, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT PRE-OP, AMPLIFIER WAS NOT WORKING AND LED WAS NOT TURNING ON. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410594 ↗
• MalfunctionJun 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Component Missing; Incorrect, Inadequate or Imprecise Result or Readings; Component Missing

  IT WAS REPORTED THAT THE PREAMPLIFIER HAD A FAILURE AND MISSING PART. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355226 ↗
• MalfunctionMay 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE MODULE WAS NOT CONNECTING WITH CONTROLLER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999786 ↗
• MalfunctionMay 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, PREAMPLIFIER CHANNELS WERE NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958759 ↗
• MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP, THE PREAMPLIFIER WAS NOT RECOGNIZED BY THE MAIN SYSTEM OF ECLC. THE HEAD REGISTERS BUT DOES NOT DELIVER AND THERE WAS A VISUAL INDICATOR OF ERROR MESSAGE PRESENT INDICATING THE ISSUE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566523 ↗