NA 05.001.231Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982130143), received between Oct 4, 2019 and May 28, 2025 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE LID DEVICE HANDPIECE COVER WAS DEFECTIVE WITH A RISK OF DETACHMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096318 ↗
• MalfunctionApr 23, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT, AND THE LOCKING MECHANISM WAS STIFF/STUCK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK MODE SWITCH LOCKING FUNCTION WITHOUT HANDPIECE. 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 21891698 ↗
• MalfunctionOct 2, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED FROM CHILE THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE OVERHEATED AND IT WAS DIFFICULT TO ATTACH IT TO THE MOTOR DEVICE WAS FRACTURED, RUNS IN THE LOCKED POSITION, THE LOCKING MECHANISM DID NOT FUNCTION AND MOVING PARTS DID NOT MOVE SMOOTHLY. THE DEVICE FAILED PRETESTS FOR CHECK THE MODE SWITCH LOCKING FUNCTION WITH HANDPIECE, CHECK THE LID LOCKING FUNCTION WITH HANDPIECE, CHECK IN ¿LOCK¿ MODE AND CHECK THE FUNCTION WITH POWER MODULE AND HANDPIECE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. 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 20351453 ↗
• InjurySep 27, 2024Premature Separation; Premature Separation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, A BATTERY HANDPIECE DEVICE AND A LID FOR HANDPIECE DEVICE WERE USED TOGETHER. ACCORDING TO THE REPORT, THE DEVICES WERE TESTED AT THE BEGINNING OF THE PROCEDURE BEFORE INCISING THE PATIENT¿S SKIN, BUT THEY WERE NOT ABLE TO CLOSE THE LID DEVICE ON THE BATTERY HANDPIECE DEVICE. IT WAS REPORTED THAT THE SURGICAL TEAM WAS ALREADY STERILE, AND THE PATIENT WAS ALREADY UNDER SPINAL ANESTHESIA WHEN THE EVENT OCCURRED. IT WAS REPORTED THAT THEY TRIED USING ANOTHER HANDPIECE DEVICE FROM A COMPETITOR¿S BRAND BUT IT DID NOT FIT THE INSERTION SYSTEM FOR THE DRILLS. IT WAS REPORTED THAT ALTHOUGH AN ATTEMPT WAS MADE TO SOLVE THIS PROBLEM WITH THE CLOSURE OF THE HANDPIECE DEVICE WITH THE LID DEVICE, THEY DECIDED TO CANCEL THE PROCEDURE. THE STATUS OF THE PATIENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20327543 ↗
• MalfunctionSep 3, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED FROM GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE LOCKING MECHANISM DID NOT FUNCTION, HAD FLUID INGRESS AND RUN IN THE LOCKED POSITION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. 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 20126072 ↗
• MalfunctionMay 15, 2024Premature Separation; Premature Separation

  IT WAS REPORTED FROM GERMANY THAT THE LID ON THE LID-HANDPIECE DEVICE OPENED WHILE USING THE MACHINE. 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 2024. 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 19318195 ↗
• MalfunctionMar 14, 2024Device Slipped; Premature Separation; Device Slipped; Premature Separation

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM JAPAN THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LID OF TWO HANDPIECE DEVICE CAME LOOSE. IT WAS REPORTED THAT AFTER THE PROCEDURE, THE DEVICES WERE CHECKED BY ALIGNING THE LID MARKS AND TWISTING TO LOCK AND ALIGNING THE KNOB ON THE BACK OF THE LID WITH THE LOCK MARK. THEN, THE LID BODY TURNED AND CAME OFF, EVEN THOUGH IT WAS NOT SUPPOSED TO TURN. THIS FAILURE OCCURRED WITH BOTH DEVICES. 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; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. 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 18904143 ↗
• MalfunctionFeb 27, 2024Fail-Safe Problem; Appropriate Device Problem Term/Code Not Available; Fail-Safe Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED FROM INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HANDPIECE WOULD RUN IN THE LOCKED POSITION WHEN THE LID IS IN THE "LOCK" POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK IN ¿LOCK¿ MODE AND CHECK THE FUNCTION WITH POWER MODULE AND HANDPIECE. 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. 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 18790698 ↗
• MalfunctionDec 14, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED FROM JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID DEVICE LOCKING MECHANISM DID NOT FUNCTION AND HAD UNINTENDED/UNEXPECTED DISENGAGEMENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE MODE SWITCH LOCKING FUNCTION WITHOUT HANDPIECE AND CHECK THE LID LOCKING FUNCTION WITH THE HANDPIECE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE COVER WAS UNABLE TO BE LOCKED. 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, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325761 ↗
• MalfunctionAug 31, 2023Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE KNOB OF THE LID HANDPIECE DEVICE MOVED TO UNLOCK WITHOUT PRESSING THE BUTTON. 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 17665765 ↗
• MalfunctionAug 25, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID-HANDPIECE DEVICE RAN IN A LOCKED POSITION AND LOCKING MECHANISM DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE MODE SWITCH LOCKING FUNCTION WITHOUT HANDPIECE, CHECK THE MODE SWITCH LOCKING FUNCTION WITH HANDPIECE, CHECK THE LID LOCKING FUNCTION WITH HANDPIECE, CHECK IN ¿LOCK¿ MODE, CHECK THE FUNCTION WITH POWER MODULE AND HANDPIECE AND CHECK INCOMPATIBILITY WITH TRS RECON SAW HANDPIECE. 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 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622196 ↗
• MalfunctionMay 16, 2023Mechanical Jam; Fail-Safe Did Not Operate; Mechanical Jam; Fail-Safe Did Not Operate

  IT WAS REPORTED FROM CANADA THAT THE LID DEVICE MODE SWITCH WOULD NOT MOVE TO THE SETTINGS ON THE HANDPIECE DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE LID DEVICE WOULD RUN IN THE LOCKED POSITION. 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 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 16938024 ↗
• MalfunctionJan 18, 2023Premature Separation; Premature Separation

  IT WAS REPORTED BY INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID DEVICE HAD LEAK TIGHTNESS TEST FAILURE AND UNINTENDED/UNEXPECTED DISENGAGEMENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR LID HOUSING ROUNDNESS AND CHECK FITTING WITH HANDPIECE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING WHILE IN USE WITH A BATTERY HANDPIECE DEVICE. 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 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193849 ↗
• InjuryMay 9, 2022Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT MOTOR COVER OF THE LID-HANDPIECE DEVICE DID NOT LOCK PROPERLY AND WHEN USED IN SAW MODE, THE VIBRATIONS CAUSED THE COVER TO COME LOOSE AND THE NON-STERILE BATTERY TO FALL INTO THE SURGICAL FIELD. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 (B)(6) OF 2022. 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 14336264 ↗
• MalfunctionSep 30, 2021Premature Separation; Premature Separation

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE LID DEVICE WAS RELEASED FROM THE BATTERY HANDPIECE/MODULAR DEVICE WHEN USED IN SAW MODE AND CUTTING THE BONE DUE TO THE PRESSURE EXERTED ON THE BONE. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED SURGICAL DELAY. IT WAS NOT REPORTED WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. 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 12554077 ↗
• MalfunctionJun 3, 2021Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE LID DEVICE CAME OFF EASILY EVEN WHEN THE BUTTON WAS NOT PRESSED. 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 2021. 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 11934149 ↗
• MalfunctionFeb 23, 2021Mechanical Problem; Premature Separation; Mechanical Problem; Premature Separation

  IT WAS REPORTED FROM (B)(6) BY THE BIOMEDICAL TECHNICIAN THAT THE LID DEVICE WAS NOT LOCKING PROPERLY AND WAS UNLOCKING BY ITSELF. 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 11364623 ↗
• MalfunctionDec 8, 2020Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE LID DEVICE (MOTOR COVER) WAS NOT BLOCKED AND WHEN PUT IN SAW MODE, THE VIBRATIONS CAUSED THE COVER TO COME LOOSE AND THE BATTERY DEVICE LOST CONTACT WITH THE HANDPIECE DEVICE AND CAME OUT, CONSTITUTING A SOURCE OF POST OPERATIVE INFECTION. FURTHER INFORMATION WAS RECEIVED FROM THE REPORTER STATING THAT THE BATTERY MAY FALL INTO THE OPERATIVE FIELD CONSTITUTING RISK OF INFECTION FOR THE PATIENT. 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. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10970286 ↗
• MalfunctionSep 22, 2020Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE LID DEVICE WHILE BEING USED WITH A BATTERY HANDPIECE DEVICE LOCKING MECHANISM WAS FAULTY AND OPENED IN THE LOCK POSITION. 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. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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 10568149 ↗
• MalfunctionJan 29, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HANDPIECE DEVICE FAILED PRE-TEST FOR CHECK THE FUNCTION OF THE LOCK/UNLOCK WITH SAFETY BUTTON. IT WAS NOTED IN THE SERVICE ORDER THAT THE COVER OF THE DEVICE DID NOT HOLD. 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 Consequences Or Impact To Patient

  MAUDE report 9641655 ↗
• MalfunctionOct 4, 2019Unintended Ejection; Unintended Ejection

  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 LID DEVICE CAME OUT OF THE BATTERY HANDPIECE DEVICE AFTER IT WAS CLOSED. THERE WAS A FIFTEEN MINUTE DELAY IN THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 9157835 ↗