NA AUTOLUBE-IIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00845384000396), received between Dec 18, 2017 and Apr 6, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE FOOT CONTROL DEVICE WAS LEAKING. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE¿S HOSE RUPTURED, THE GAUGE WAS DAMAGED, AND THE DEVICE WAS LEAKING LIQUID. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, GAUGE PRESSURE, OIL LEAK INSPECTION, AND DRIP RATE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS LEAKING AIR. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693258 ↗
• MalfunctionMar 14, 2023Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE FOOT CONTROL DEVICE HAD BROKEN GAUGE COVER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE HAD A RUPTURED HOSE, DAMAGED GAUGE, AND COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE WAS UNABLE TO CONTROL IRRIGATION FLOW RATE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, GAUGE CONDITION AND DRIP RATE ASSESSMENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE INCIDENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537801 ↗
• MalfunctionFeb 7, 2023Break; Leak/Splash; Complete Loss of Power; Break; Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT THE FOOT CONTROL DEVICE WAS LEAKING OIL AND LOSING PRESSURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE HAD A RUPTURED HOSE, A LIQUID LEAK, AND A DAMAGED GAUGE. IT WAS FURTHER DETERMINED THAT THE DEVICE WAS MISSING COMPONENTS. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT AND DRIP RATE ASSESSMENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311568 ↗
• MalfunctionNov 23, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED FROM COLOMBIA THAT THE AUTO LUBE DEVICE FAILED TO CONTAIN THE LIQUID PROPERLY AND WAS LEAKING. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AUTOLUBE DEVICE GAUGE WAS DAMAGED, WAS WORN, THE HOSE HAD RAPTURED AND WAS LEAKING A LIQUID. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR GENERAL CONDITION, GAUGE CONDITION, GAUGE PRESSURE, OIL LEAK INSPECTION AND DRIP RATE ASSESSMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851954 ↗
• MalfunctionNov 20, 2020Break; Break

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE HOSE OF THE AUTOLUBE DEVICE WAS RUPTURED AND CRACKED. IT WAS FURTHER REPORTED THAT THE GAUGE WAS DAMAGED, THE BASE PLATE WAS BENT, AND THE DEVICE WAS DEFORMED/BENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, GAUGE CONDITION AND HIGH PRESSURE ASSESSMENT. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875691 ↗
• MalfunctionMar 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FROM (B)(6) THAT THE AUTOLUBE DEVICE HAD AN OIL LEAK. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER IT WAS NOTED THAT THE EVENT OCCURRED IN (B)(6) 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7379444 ↗
• MalfunctionMar 26, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRE-SURGERY SET UP, IT WAS OBSERVED THAT THE AUTOLUBE DEVICE WAS LEAKING OIL. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7369243 ↗
• MalfunctionDec 18, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FROM (B)(6) THAT THE FOOT CONTROL DEVICE WAS LEAKING OIL. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125998 ↗
• MalfunctionDec 18, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE FOOT CONTROL DEVICE WAS LEAKING OIL. IT WAS NOTED THAT THE MANOMETER WAS DEFECTIVE ON THE DEVICE, THE FOOT SWITCH WAS LOSING OIL. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125996 ↗