NA 05.001.201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,902 adverse event reports that list this exact device (DI 10886982129611), received between Nov 21, 2017 and Sep 30, 2026 — classified as 6 injuries, 1,896 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1,135 reports).

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 25 most recent of 1,902 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950440 ↗
• MalfunctionSep 29, 2026Physical Resistance/Sticking; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938377 ↗
• MalfunctionSep 25, 2026Physical Resistance/Sticking; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903389 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 50859834 ↗
• MalfunctionSep 22, 2026Physical Resistance/Sticking; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the battery handpiece device had a sticky trigger, failed the leak tightness test, the K-wire could not be inserted, the device would not hold/secure the battery, the housing was cracked/damaged, and the device had component damage. It was further determined that the device failed pretest for General condition, Leakage Test, Check the cannulation of the handpiece, Check for sticky triggers, Check the roundness of the housing, and Check falling out protection. It was noted in the service order that prior to an unspecified surgical procedure it was observed that the device did not work anymore. This event did not occur during a surgical procedure. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 50858026 ↗
• MalfunctionSep 1, 2026Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546711 ↗
• MalfunctionSep 1, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545589 ↗
• MalfunctionAug 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499915 ↗
• MalfunctionJul 1, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD A STICKY TRIGGER, CRACKED/DAMAGED HOUSING, FAILED THE LEAK TIGHTNESS TEST, WOULD NOT RUN, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR MECHANICAL FREE MOVING, CHECK FOR STICKY TRIGGERS, CHECK ROUNDNESS OF HOUSING, CHECK FITTING OF THE LID, CHECK FOR WEAR ON HOUSING, AND CHECK GENERAL FUNCTION OF DEVICE. 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 25681407 ↗
• MalfunctionJul 1, 2026Excessive Heating

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE BATTERY HANDPIECE/MODULAR FOR TRS DEVICE WAS OVERHEATING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO DELAY TO THE PROCEDURE. 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 25681090 ↗
• MalfunctionJun 30, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE/MODULAR FOR TRS DEVICE TRIGGER MOVING PARTS DID NOT MOVE SMOOTHLY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 25670010 ↗
• MalfunctionJun 26, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE/MODULAR FOR TRS DEVICE TRIGGER WAS STICKY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 25641184 ↗
• MalfunctionJun 26, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE [BATTERY HANDPIECE/MODULAR FOR TRS DEVICE TRIGGER WAS STICKY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 25641017 ↗
• MalfunctionJun 23, 2026Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD A STICKY TRIGGER, THE DEVICE FAILED THE LEAK TIGHTNESS TEST AND WOULD NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR MECHANICAL FREE MOVING, AND CHECK FOR STICKY TRIGGERS, AND CHECK GENERAL FUNCTION OF DEVICE. IT WAS NOTED IN THE SERVICE ORDER THAT THE SWITCH WAS GETTING STUCK. 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 25599543 ↗
• MalfunctionJun 22, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD A STICKY TRIGGER, THE HOUSING WAS CRACKED/DAMAGED, FAILED THE LEAK TIGHTNESS TEST, AND WOULD NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR MECHANICAL FREE MOVING, CHECK FOR STICKY TRIGGER, CHECK ROUNDNESS OF THE HOUSING, CHECK FALLING OUT PROTECTION, CHECK FITTING OF THE LID, CHECK FOR WEAR ON THE HOUSING, AND CHECK GENERAL FUNCTION OF THE DEVICE. 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 25578926 ↗
• MalfunctionJun 22, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD MOVING PARTS DO NOT MOVE SMOOTHLY - TRIGGER. 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 25576995 ↗
• MalfunctionJun 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE/MODULAR DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563783 ↗
• MalfunctionJun 19, 2026Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TRIGGER OF THE BATTERY HANDPIECE/MODULAR DEVICE WAS BLOCKED. THE BATTERY LID DID NOT LOCK. 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. 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 25563377 ↗
• MalfunctionJun 16, 2026Unintended System Motion

  IT WAS REPORTED THAT THE BATTERY HANDPIECE DEVICE WOULD SOMETIMES TURN ON ON ITS OWN. NO FURTHER INFORMATION WAS PROVIDED BY THE REPORTER. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25517695 ↗
• MalfunctionJun 12, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE FAILED THE LEAK TIGHTNESS TEST, HAD A STICKY TRIGGER, THE HOUSING WAS DEFORMED/BENT, AND THE DEVICE WOULD NOT HOLD/SECURE THE BATTERY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR STICKY TRIGGERS, CHECK ROUNDNESS OF HOUSING, CHECK FALLING OUT PROTECTION, AND CHECK FOR WEAR ON HOUSING. IT WAS NOTED IN THE SERVICE ORDER THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DEVICE DID NOT WORK ANYMORE. 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. 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 25483829 ↗
• MalfunctionJun 8, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE FAILED THE LEAK TIGHTNESS TEST, HAD A STICKY TRIGGER, AND THE COLOR BAND WAS CHIPPING/FADING. IT WAS NOTED THAT THE MOTOR DID NOT WORK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, AND CHECK FOR STICKY TRIGGERS. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK ANYMORE. 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. 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 25435800 ↗
• MalfunctionJun 8, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE/MODULAR FOR TRS DEVICE TRIGGER WAS STICKY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 25434084 ↗
• MalfunctionJun 3, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD A STICKY TRIGGER, FAILED THE LEAK TIGHTNESS TEST, AND WOULD NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR STICKY TRIGGERS, AND CHECK GENERAL FUNCTION OF DEVICE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 25382286 ↗
• MalfunctionJun 1, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION; IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 25351810 ↗
• MalfunctionMay 28, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE/MODULAR FOR TRS DEVICE TRIGGER WAS STICKY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 25323088 ↗