NA 532.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982240569), received between Jul 31, 2020 and Apr 8, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2025Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE RAN IN THE LOCKED POSITION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21797269 ↗
• MalfunctionNov 27, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REDUCTION DRIVE UNIT HAD COSMETIC DAMAGE, AND THE DEVICE WOULD RUN IN THE LOCKED POSITION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. 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 20791535 ↗
• MalfunctionApr 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED FROM JAPAN THAT THE MODIFIED TRINKLE REDUCTION DRIVE UNIT 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 A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. 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 19183370 ↗
• MalfunctionFeb 1, 2023Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT MODIFIED TRINKLE REDUCTION DRIVE DEVICE HAD NO REVERSE MOTION OR WAS IN REVERSE MOTION AS IT CONTINUED SPINNING THE GAUGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE RAN IN LOCKED POSITION. 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 EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2023. 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 16279923 ↗
• MalfunctionJul 31, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT THE REDUCTION DRIVE DEVICE OVERHEATED. 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 THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2020. 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 10350537 ↗