NA OCMRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845384017493), received between Aug 2, 2018 and May 16, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K131053); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE OTOLOGIC CURVED ATTACHMENT DEVICE WAS NOT WORKING PROPERLY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE GENERATED HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD CORROSION/RUSTING/PITTING, AND THE LABELING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, AND TEMPERATURE ASSESSMENTS. 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. 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 14407068 ↗
• MalfunctionMar 30, 2020Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS VIBRATING WHEN ATTACHED TO THE MOTOR DEVICE. IT WAS REPORTED THAT THE MOTOR WAS TESTED WITH OTHER ATTACHMENTS AND THE ATTACHMENT DEVICES WORKED FINE. 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. 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 9900391 ↗
• MalfunctionAug 2, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS OVERHEATING. 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 THIS EVENT 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 Consequences Or Impact To Patient

  MAUDE report 7741902 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131053. One submission often covers many models, so check the product and lot details in each record.

• Z-2016-2017 · Oct 6, 2016 · Terminated
  Otologic Curved Micro Product Usage: Pneumatic system
• Z-1667-2016 · Mar 28, 2016 · Terminated
  ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for
• Z-1668-2016 · Mar 28, 2016 · Terminated
  ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cut