NA SC2101Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845384011972), received between Nov 29, 2017 and May 19, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 reports).

35 other recalls cover devices cleared under the same FDA submission (K080802); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE THAT THE ELECTRONIC CONTROL UNIT ON THE CONSOLE DEVICE WAS DEFECTIVE. IT WAS FURTHER REPORTED THAT THE DEVICE HAD NO CLEAR INFORMATION ON THE DISPLAY AND THE LIGHT EMITTING DIODES FLASHED RANDOMLY AND THEREFORE NO SYMBOLS COULD BE SEEN ON THE DISPLAY. IT WAS ALSO DETERMINED THAT THE DEVICE FAILED PRE-TEST FOR MOTOR LOCK ASSESSMENT, HAND CONTROL, ROTATION DIRECTION, AIR PUMP TEST, IRRIGATION PUMP, FOOT PEDAL, FOOT PEDAL IRRIGATION CONTROL AND MANUAL SPEED CONTROL. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10072654 ↗
• MalfunctionJan 10, 2018Overheating of Device; Device Displays Incorrect Message; Overheating of Device; Device Displays Incorrect Message

  THIS IS EVENT 2 OF 2 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING A CHOLESTEATOMA EAR, NOSE AND THROAT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE HAD MULTIPLE INTERMITTENT FAILURES AND THE CONSOLE DISPLAYED AN E8 SYSTEM FAULT ERROR CODE. IT WAS FURTHER REPORTED THAT A WHILE LATER, THE CONSOLE DISPLAYED AN E5 FAULT AND WAS ONCE AGAIN RECTIFIED BY TECHNICIAN ON-SITE. ACCORDING TO THE REPORTER, THIS WAS ALSO FOLLOWED BY SMOKE COMING OUT FROM THE CONSOLE DEVICE WHICH WAS PRESUMED DUE TO BEING OVER HEATED. THE SYSTEM WAS STILL FUNCTIONAL AFTER A PAUSE OF ABOUT 30 MINUTES. THE E5 CODE WAS DISPLAYED TWO MORE TIMES AFTER WHICH WAS NOTED DUE TO LOOSE CONNECTION BETWEEN THE HANDPIECE AND THE CONSOLE THERE WAS A THIRTY MINUTE DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE CASE WAS COMPLETED USING THE SAME SET. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 7179782 ↗
• MalfunctionDec 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS EVENT 2 OF 2 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE WOULD NOT MAKE A HOLE WITH THE TREPAN AND THE PATIENT'S HAIR STARTED TO BURN. IT WAS FURTHER REPORTED THAT THE SURGEON HAD TO MAKE THE HOLE MANUALLY WITH A CRANIOTOME INSTEAD OF THE MOTOR DEVICE. IT WAS REPORTED THAT THE MOTOR DEVICE WAS IN USE WITH THE CONSOLE DEVICE WHEN THE EVENT OCCURRED. THERE WAS A TEN MINUTE DELAY TO THE SURGICAL PROCEDURE DUE TO THE EVENT. THERE WAS PATIENT INVOLVEMENT. THE PATIENT'S HAIR WAS BURNED. THERE WAS NO MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION 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 7123491 ↗
• MalfunctionNov 29, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED FROM THE (B)(6) THAT DURING SURGERY, BEFORE USE ON A PATIENT, IT WAS OBSERVED THAT THE CONSOLE DEVICE HAD AN E8 ERROR CODE AND THE DIODES WERE FUNCTIONLESS. 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 THAT 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 7069817 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080802. One submission often covers many models, so check the product and lot details in each record.

• Z-2031-2017 · Oct 6, 2016 · Terminated
  Sagittal MICRO-SAW
• Z-2015-2017 · Oct 6, 2016 · Terminated
  Sagittal Saw Product Usage: Pneumatic system
• Z-1955-2017 · Oct 6, 2016 · Terminated
  Console, eMax2 Plus Product Usage: Electric system
• Z-2026-2017 · Oct 6, 2016 · Terminated
  Reciprocating MICRO SAW
• Z-1952-2017 · Oct 6, 2016 · Terminated
  eMax2 PLUS Product Usage: Electric system
• Z-2019-2017 · Oct 6, 2016 · Terminated
  Oscillating MICRO-SAW Product Usage: Pneumatic system
• Z-1957-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, no irrigation
• Z-1949-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
• Z-1948-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction Switch Product Usage: Electric system
• Z-1956-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, with irrigation Product Usage: Electric system
• Z-2001-2017 · Oct 6, 2016 · Terminated
  12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
• Z-2032-2017 · Oct 6, 2016 · Terminated
  20.2cm Heavy Duty Long Heavy Short Attachment
• Z-0727-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM C
• Z-0728-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine
• Z-0729-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and

…and 20 more.