NA SC2100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845384008606), received between Dec 1, 2017 and Dec 6, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED FROM JAPAN THAT THE MOTOR DEVICE WAS HAD ERROR DISPLAYED. 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 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 18275320 ↗
• MalfunctionJul 30, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED FROM (B)(6) THAT THE MOTOR DEVICE, WHILE BEING USED WITH THE CONSOLE DEVICE, HAD AN E6 (OVERHEAT WARNING) ERROR CODE AND COULD NOT BE USED. 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 10346984 ↗
• MalfunctionJan 19, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CONSOLE DEVICE HAD AN UNSPECIFIED ERROR OCCUR. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. 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 Known Impact Or Consequence To Patient

  MAUDE report 7205530 ↗
• MalfunctionDec 1, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A CADAVER LAB EDUCATIONAL PROGRAM, THE CONSOLE DEVICE WAS DISPLAYING A FALSE E6 (OVERHEAT WARNING) ERROR CODE ON MULTIPLE DRILLS BUT THERE WAS NO HEAT PRESENT IN ANY OF THE DRILLS AND HAD A STRANGE VIBRATING NOISE THAT SOUNDED LIKE A BROKEN DOWN REFRIGERATOR. 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 Known Impact Or Consequence To Patient

  MAUDE report 7075857 ↗

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-1952-2017 · Oct 6, 2016 · Terminated
  eMax2 PLUS 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-2026-2017 · Oct 6, 2016 · Terminated
  Reciprocating MICRO SAW
• Z-1955-2017 · Oct 6, 2016 · Terminated
  Console, eMax2 Plus Product Usage: Electric 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-2031-2017 · Oct 6, 2016 · Terminated
  Sagittal MICRO-SAW
• Z-2019-2017 · Oct 6, 2016 · Terminated
  Oscillating MICRO-SAW Product Usage: Pneumatic system
• Z-2015-2017 · Oct 6, 2016 · Terminated
  Sagittal Saw Product Usage: Pneumatic system
• Z-2032-2017 · Oct 6, 2016 · Terminated
  20.2cm Heavy Duty Long Heavy Short Attachment
• Z-2001-2017 · Oct 6, 2016 · Terminated
  12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
• 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
• 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

…and 20 more.