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NA EG1ARecalls & reported problems

Synthes GmbH · G1 High Speed Electric Handpiece, Air Cooled · Class 2

Quick summary

This Synthes G1 High Speed electric handpiece is an air-cooled surgical drill handpiece used in ENT surgery. Most of the 858 reports describe the handpiece overheating, and others describe power loss, unusual noise and vibration, while a few mention burns. The reports include 5 injuries and no deaths. Reports from the past year number 7, down from 89 in the year before. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
859
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 859 adverse event reports that list this exact device (DI 00845384017134), received between Dec 4, 2017 and Sep 17, 2026 — classified as 5 injuries, 854 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (587 reports).

11 other recalls cover devices cleared under the same FDA submission (K133604); 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.

Reports received per month

Nov 2023: 12 reportsDec 2023: 13 reportsJan 2024: 9 reportsFeb 2024: 10 reportsMar 2024: 11 reportsApr 2024: 9 reportsMay 2024: 7 reportsJun 2024: 5 reportsJul 2024: 6 reportsAug 2024: 6 reportsSep 2024: 6 reportsOct 2024: 10 reportsNov 2024: 11 reportsDec 2024: 8 reportsJan 2025: 9 reportsFeb 2025: 10 reportsMar 2025: 5 reportsApr 2025: 9 reportsMay 2025: 13 reportsJun 2025: 6 reportsJul 2025: 8 reportsAug 2025: 6 reportsSep 2025: 2 reportsOct 2025: 2 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202613
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Excessive Heating587
  • Overheating of Device81
  • Complete Loss of Power77
  • Noise, Audible73
  • Unintended System Motion69
  • Vibration59
  • Appropriate Device Problem Term/Code Not Available55
  • Device-Device Incompatibility32

Patient problems

  • No Clinical Signs, Symptoms or Conditions615
  • No Consequences Or Impact To Patient202
  • No Known Impact Or Consequence To Patient38
  • Burn(s)5
  • Injury2
  • Superficial (First Degree) Burn1

Recent adverse event reports

The 25 most recent of 859 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 17, 2026Excessive Heating

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50809031 ↗
  • MalfunctionAug 5, 2026Complete Loss of Power; Excessive Heating

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50142865 ↗
  • MalfunctionJun 26, 2026Vibration; Noise, Audible; Excessive Heating

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HIGH SPEED ELEC G1 HANDPIECE AIR COOLED DEVICE WAS HEATING UP AND VIBRATING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE MADE ABNORMAL NOISE 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25641363 ↗
  • MalfunctionMar 11, 2026Overheating of Device

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION; IT WAS DETERMINED THAT THE HANDPIECE DEVICE HAD HEAT. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24568021 ↗
  • MalfunctionFeb 25, 2026Vibration; Device-Device Incompatibility; Excessive Heating

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HANDPIECE DEVICE WAS MAKING EXCESSIVE NOISE, HAD VIBRATION, COSMETIC DAMAGE, AND HEAT. IT WAS NOTED THAT THE CONNECTOR RED INDICATOR WAS FADING, OVERHEATING, ABNORMAL NOISE, AND VIBRATION WAS PRESENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, TEMPERATURE VERIFICATION, AND NOISE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE COULD NOT ENGAGE THE ATTACHMENT. 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 NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. 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 24443662 ↗
  • MalfunctionFeb 4, 2026Excessive Heating

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE MOTOR DEVICE HAD AN ABNORMALLY HIGH TEMPERATURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24259790 ↗
  • MalfunctionDec 22, 2025Energy Output Problem; Overheating of Device; Energy Output Problem; Overheating of Device

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HANDPIECE DEVICE HAD HEAT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE SPEED WOULD NOT RISE. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23870310 ↗
  • MalfunctionNov 11, 2025Device Alarm System; Environmental Particulates; Excessive Heating; Device Alarm System; Environmental Particulates; Excessive Heating

    IT WAS REPORTED FROM THAT THE HANDPIECE DEVICE DISPLAYED AN E1-E8 ERROR CODE, WAS OVERHEATING AND HAD A SMOKE ISSUE. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23521693 ↗
  • MalfunctionOct 21, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE HANDPIECE DEVICE BECAME WARM. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23345308 ↗
  • MalfunctionOct 15, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE MOTOR DEVICE WAS HEATING UP. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23303083 ↗
  • MalfunctionSep 8, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE HANDPIECE DEVICE MOTOR WAS HEATING UP. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22990449 ↗
  • MalfunctionSep 5, 2025Unintended System Motion; Unintended System Motion

    IT WAS REPORTED THAT THE MOTOR DEVICE WAS MOVING WITHOUT STEPPING ON THE PEDAL. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22977087 ↗
  • MalfunctionAug 29, 2025Device Alarm System; Overheating of Device; Device Alarm System; Overheating of Device

    IT WAS REPORTED THAT THE HANDPIECE DEVICE HAD A CT ERROR WHEN STEPPING ON THE FOOT PEDAL. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD WEAR, CORROSION/RUSTING/PITTING, INTERMITTENT OPERATION AND HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL, BREAK OUT BOX MOTOR ASSESSMENT, CUTTER AND TEMPERATURE VERIFICATION. 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 22920833 ↗
  • MalfunctionAug 26, 2025Fluid/Blood Leak; Overheating of Device; Fail-Safe Problem; Noise, Audible; Fluid/Blood Leak; Overheating of Device; Fail-Safe Problem; Noise, Audible

    IT WAS REPORTED THAT THE HANDPIECE DEVICE MADE A RATTLING SOUND WHEN TURNED ON. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A LIQUID LEAK, HEAT, RAN IN THE LOCKED POSITION AND HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR BREAK OUT BOX MOTOR ASSESSMENT AND SAFETY CHECK. 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 22893864 ↗
  • MalfunctionAug 25, 2025Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

    IT WAS REPORTED THAT THE HANDPIECE DEVICE WOULD NOT WORK WHEN TESTED. IT WAS DETERMINED THAT THE DEVICE PRODUCED HEAT, WAS LOOSE, COULD NOT SECURE/LOCK CUTTER, HAD CORROSIONS/RUSTING/PITTING AND COSMETIC DAMAGE-WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, CUTTER ASSESSMENT TEMPERATURE VERIFICATION AND CONNECTOR LOCTITE ASSESSMENT. 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 22884317 ↗
  • MalfunctionAug 22, 2025Output below Specifications; Noise, Audible; Complete Loss of Power; Excessive Heating; Output below Specifications; Noise, Audible; Complete Loss of Power; Excessive Heating

    IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE MOTOR DEVICE DID NOT WORK, MADE A WEIRD NOISE, AND WAS NOT FAST ENOUGH. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE PRODUCED HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION AND MADE AN EXCESSIVE NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR BREAK OUT BOX MOTOR ASSESSMENTS, TEMPERATURE VERIFICATIONS AND PUMP ASSESSMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22871984 ↗
  • MalfunctionAug 14, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE HANDPIECE DEVICE WAS OVERHEATING/GETTING HOT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22804856 ↗
  • MalfunctionAug 5, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT THE HANDPIECE DEVICE WAS HAVING AN OVERHEATING ISSUE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22715043 ↗
  • MalfunctionJul 22, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE MOTOR DEVICE WAS GETTING HOT. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22568385 ↗
  • MalfunctionJul 18, 2025Unintended System Motion; Unintended System Motion

    IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS OBSERVED THAT THE DRILL BIT HANDPIECE DEVICE WAS TURNING ON ITS OWN. 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 NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. 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 22545141 ↗
  • MalfunctionJul 15, 2025Separation Failure; Mechanical Jam; Excessive Heating; Separation Problem; Separation Failure; Mechanical Jam; Excessive Heating; Separation Problem

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE WAS STUCK ON THE HANDPIECE DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE HANDPIECE DEVICE HAD HEAT. 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 NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. 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 22507517 ↗
  • MalfunctionJul 15, 2025Fail-Safe Problem; Fail-Safe Problem

    IT WAS REPORTED THAT THE HANDPIECE DEVICE HAD AN UNSPECIFIED FAILURE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE RAN IN THE LOCKED POSITION, HAD NOISE, BROKEN DIAMOND KEY AND FAILED PRE-TEST FOR SAFETY CHECK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22505861 ↗
  • MalfunctionJul 10, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HANDPIECE DEVICE HAD HEAT AND THE ETCHING WAS ILLEGIBLE. 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 NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. 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 22470045 ↗
  • MalfunctionJul 7, 2025Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

    IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE WAS NOT WORKING PROPERLY. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE MOVING PARTS DID NOT MOVE SMOOTHLY, DISPLAYED AN A-1 ERROR CODE, THE LABELING ETCHING WAS ILLEGIBLE, HAD COMPONENT DAMAGE, COULD NOT ENGAGE ATTACHMENT AND HEATED UP. THE DEVICE ALSO FAILED PRETESTS FOR VISUAL ASSESSMENT, ATTACHMENT ASSESSMENT, TEMPERATURE VERIFICATION AND AIR PUMP ASSESSMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22413251 ↗
  • MalfunctionJul 3, 2025Overheating of Device; Complete Loss of Power; Overheating of Device; Complete Loss of Power

    IT WAS REPORTED THAT THE HANDPIECE DEVICE DID NOT FUNCTION. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD HEAT, ILLEGIBLE ETCH AND COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST ASSESSMENTS FOR VISUAL AND TEMPERATURE VERIFICATION. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22395081 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133604. One submission often covers many models, so check the product and lot details in each record.

  • Z-0924-2023 · Dec 7, 2022 · Open, Classified
    Pediatric Craniotome Ref:CRANI-P-G1
  • Z-0922-2023 · Dec 7, 2022 · Open, Classified
    7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
  • Z-0919-2023 · Dec 7, 2022 · Open, Classified
    6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
  • Z-0923-2023 · Dec 7, 2022 · Open, Classified
    6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
  • Z-0916-2023 · Dec 7, 2022 · Open, Classified
    6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
  • Z-0920-2023 · Dec 7, 2022 · Open, Classified
    7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
  • Z-0921-2023 · Dec 7, 2022 · Open, Classified
    Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
  • Z-0917-2023 · Dec 7, 2022 · Open, Classified
    6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and crani
  • Z-0918-2023 · Dec 7, 2022 · Open, Classified
    Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
  • Z-2253-2016 · Jun 15, 2016 · Terminated
    Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
  • Z-1037-2015 · Dec 10, 2014 · Terminated
    16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices

All DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.