NA MA-15SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00845384004332), received between Jun 10, 2019 and Sep 27, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 reports).

31 other recalls cover devices cleared under the same FDA submission (K042783); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Premature Separation; Premature Separation

  THIS IS REPORT 1 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM JAPAN THAT THE BURR DEVICE DETACHED FROM THE BEARING SLEEVE DEVICE. 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. 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 17827209 ↗
• MalfunctionJun 11, 2019Overheating of Device; Overheating of Device

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT THREE BEARING SLEEVE DEVICES WERE HEATING UP. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 8686818 ↗
• MalfunctionJun 11, 2019Overheating of Device; Overheating of Device

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT THREE BEARING SLEEVE DEVICES WERE HEATING UP. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 8686817 ↗
• MalfunctionJun 11, 2019Overheating of Device; Overheating of Device

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT THREE BEARING SLEEVE DEVICES WERE HEATING UP. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 8686814 ↗
• MalfunctionJun 10, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE BEARING SLEEVE DEVICE WAS OVERHEATING. 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. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT IS UNKNOWN. ALL AVAILABLE HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION WERE TO BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8684113 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042783. One submission often covers many models, so check the product and lot details in each record.

• Z-2011-2017 · Oct 6, 2016 · Terminated
  Minimal Access Straight Driver Product Usage: Pneumatic system
• Z-2004-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system
• Z-2006-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system
• Z-2007-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system
• Z-2005-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system
• Z-2009-2017 · Oct 6, 2016 · Terminated
  Minimal Access Attachment Product Usage: Pneumatic system
• Z-2003-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system
• Z-0708-2014 · Oct 26, 2012 · Terminated
  Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, M
• Z-0764-2014 · Mar 29, 2012 · Terminated
  MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as co
• Z-0753-2014 · Mar 29, 2012 · Terminated
  MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as c
• Z-0767-2014 · Mar 29, 2012 · Terminated
  MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as coch
• Z-0766-2014 · Mar 29, 2012 · Terminated
  MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochl
• Z-0756-2014 · Mar 29, 2012 · Terminated
  MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochl
• Z-0769-2014 · Mar 29, 2012 · Terminated
  MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as coch
• Z-0759-2014 · Mar 29, 2012 · Terminated
  MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as coch

…and 16 more.