NA 05.001.204Recalls & reported problems
Synthes GmbH · UNIVERSAL BATTERY CHARGER II · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886982129666), received between Dec 6, 2017 and May 26, 2026 — classified as 1 injury, 21 malfunctions.
The most frequently reported specific device problem is “Fire” (17 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.
Reports received per month
Most reported problems
Device problems
- Fire17
- Complete Loss of Power4
- Environmental Particulates3
- Appropriate Device Problem Term/Code Not Available2
- Noise, Audible2
- Adverse Event Without Identified Device or Use Problem1
- Overheating of Device1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient2
- Electric Shock1
- Limb Fracture1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Fire; Environmental Particulates; Noise, Audible
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION THE UNIVERSAL BATTERY CHARGER EXPERIENCED SPARK/FIRE. IT WAS NOTED IN THE SERVICE ORDER THAT WHILE SETTING UP FOR A LAB WITH CADAVERIC EQUIPMENT THEY PLUGGED THE BATTERY CHARGER INTO THE WALL AND THEN INTO THE BATTERY BANK AND PRESSED THE ON BUTTON. A LOUD POP OR BANG OCCURRED AND SMOKE IMMEDIATELY POURED FROM THE BACK OF THE CHARGING BANK. THEY UNPLUGGED THE CHARGER FROM THE WALL AND LEFT IT FOR TWO HOURS TO ENSURE IT DID NOT CONTINUE SMOKING. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED AS THE DEVICE AS FOR CADAVER USE ONLY. 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 25280531 ↗MalfunctionNov 17, 2025Fire; Environmental Particulates; Noise, Audible; Fire; Environmental Particulates; Noise, Audible
IT WAS REPORTED FROM THAT WHEN THE UNIVERSAL BATTERY CHARGER DEVICE WAS SWITCHED ON, IT WAS OBSERVED THAT IT MADE A CRACKLING SOUND FOLLOWED BY A POP, THE CHARGER EMITTED SPARKS, STARTED TO SMOKE, AND THEN THE FUSES IN THE CLINIC BLEW. IT WAS REPORTED THAT THE DEVICE CHARGER WAS THEN IMMEDIATELY UNPLUGGED. 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 23567306 ↗MalfunctionJul 2, 2025Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED THAT WHILE USING THE UNIVERSAL BATTERY CHARGER DEVICE, WHEN SWITCHING ON THE BATTERY CHARGER ON/OFF SWITCH THE ELECTRICAL FACILITY PROTECTION WOULD SHUT DOWN. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THE USER FELT A SMALL ANT HILL IN THE FINGERS (TINGLING SENSATION LIKE A SHOCK). 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: Electric Shock
MAUDE report 22383157 ↗MalfunctionMay 2, 2025Fire; Appropriate Device Problem Term/Code Not Available; Complete Loss of Power; Fire; Appropriate Device Problem Term/Code Not Available; Complete Loss of Power
IT WAS REPORTED THAT THE BATTERY CHARGER DEVICE SPARKED, SHORTED OUT, AND STOPPED 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 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 21953834 ↗MalfunctionMar 8, 2024Fire; Fire
IT WAS REPORTED FROM SOUTH KOREA THAT WHEN THE BATTERY DEVICE WAS ATTACHED TO THE UNIVERSAL BATTERY CHARGER DEVICE, A SPARK WAS PRODUCED. 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 18869464 ↗MalfunctionJan 11, 2024Fire; Fire
IT WAS REPORTED BY JAPAN THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT WHEN THE UNIVERSAL BATTERY CHARGER DEVICE WAS PLUGGED IN AND TURNED ON, SPARKS FLEW. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 18490879 ↗MalfunctionSep 6, 2023Fire; Fire
IT WAS REPORTED THAT THE UNIVERSAL BATTERY CHARGER HAD SPARKS. IT WAS REPORTED THAT THE DEVICE WAS NOT USED IN SURGERY. IT WAS NOT REPORTED 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 FOR USE. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17694509 ↗MalfunctionMay 8, 2023Fire; Complete Loss of Power; Fire; Complete Loss of Power
IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY CHARGER DEVICE WOULD NOT RUN ¿ POWER SUPPLY WAS DAMAGED, HAD A BLOWN FUSED, SPARK/FIRE, AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FIRMWARE REVISION AND POWER-ON TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD NO POWER. 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 16889501 ↗MalfunctionApr 18, 2023Fire; Fire
IT WAS REPORTED THAT THE UNIVERSAL BATTERY CHARGER DEVICE SPARKED WHEN IT WAS TURNED ON. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16760785 ↗MalfunctionFeb 10, 2023Fire; Complete Loss of Power; Fire; Complete Loss of Power
IT WAS REPORTED THAT THE BATTERY CHARGER DEVICE HAD NO POWER. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WOULD NOT CHARGE, HAD SPARK/FIRE, AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR POWER-ON TEST. 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 16353022 ↗MalfunctionJan 3, 2023Fire; Appropriate Device Problem Term/Code Not Available; Complete Loss of Power; Fire; Appropriate Device Problem Term/Code Not Available; Complete Loss of Power
IT WAS REPORTED THAT THE UNIVERSAL BATTERY CHARGER DEVICE HAD NO POWER AND NEEDED TO BE UPDATED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE FUSE WAS BLOWN, THERE WAS A SPARK/FIRE, WOULD NOT RUN BECAUSE THE POWER SUPPLY WAS DAMAGED, HAD COSMETIC DAMAGE AND THE EDGES WERE SHARP. THE DEVICE ALSO FAILED PRETESTS FOR GENERAL CONDITION, CHECK FIRMWARE REVISION, POWER-ON TEST, CHARGER SELF-CHECK, REFRESH / STRESS TEST AND CHARGING FUNCTION WITH TRS POWER MODULE AND BATTERIES. 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 DATE OF 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 Clinical Signs, Symptoms or Conditions
MAUDE report 16085377 ↗MalfunctionDec 16, 2022Fire; Fire
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT CIRCUIT BOARD OF THE UNIVERSAL BATTERY CHARGER WAS MAKING SPARKS DURING POWER UP. 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, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. 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 15995928 ↗MalfunctionAug 16, 2022Sparking; Sparking
IT WAS REPORTED THAT DURING A LAB THE BATTERY CHARGER DEVICE SPARKED WHEN POWERED ON. THIS EVENT DID NOT OCCUR DURING SURGERY. IT WAS REPORTED THAT THIS DEVICE HAS NEVER BEEN USED IN A SURGICAL SETTING WITH A LIVE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions
MAUDE report 15235324 ↗MalfunctionJun 9, 2022Fire; Environmental Particulates; Fire; Environmental Particulates
IT WAS REPORTED THAT THE UNIVERSAL BATTERY CHARGER DEVICE SPARKED WHEN CHARGING THE BATTERY AND THEN SMOKE CAME OUT FROM THE DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14644496 ↗MalfunctionApr 7, 2022Fire; Fire
IT WAS REPORTED FROM (B)(6) THAT WHILE RECONNECTING THE UNIVERSAL BATTERY CHARGER WITH POWER, A SPARK WAS OBSERVED. THE DEVICE HAD PREVIOUSLY BEEN DISCONNECTED FROM POWER WITH POWER MODULE ALREADY INSTALLED IN CHARGING BAYS. 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. 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 14040027 ↗InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING A TOTAL HIP ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ADAPTOR DEVICE COULD NOT BE REMOVED FROM THE IMPACTOR DEVICE. ACCORDING TO THE REPORTER, THE IMPACTION WAS BEING PERFORMED FROM SIZE 8 BROACH BY ATTACHING THE BROACH ADAPTER TO THE SURGICAL IMPACTOR DURING BROACHING. AFTER REACHING THE SIZE 10 BROACH, THE SURGICAL IMPACTOR ADAPTER DEVICE COULD NOT BE REMOVED WHEN THE SURGEON TRIED TO REMOVE IT FROM THE BROACH. IT WAS NOTED THAT THERE WERE NO PROBLEMS FROM SIZE 8 TO 9 BROACHES, HOWEVER FROM SIZE 10, THE BROACH COULD NOT BE ATTACHED. DUE TO THIS, THE LEVER OF THE BROACH WAS OPENED AND SLIGHTLY PULLED, AND IMPACT WAS APPLIED ONCE WITH SURGICAL IMPACTOR ADAPTER AND THE DEVICE COULD THEN BE REMOVED. AFTER THAT, THE SURGEON TRIED TO ATTACH THE SURGICAL IMPACTOR ADAPTER DEVICE TO THE BROACH AGAIN, BUT THE NECK OF THE BROACH DID NOT GO INTO THE BROACH ADAPTER AND COULD NOT BE ATTACHED. THEREFORE, THE SURGEON REPLACED IT WITH AN ANTERIOR BROACH HANDLE AND MANUALLY REMOVED THE SIZE 10 BROACH. SIZE 11 BROACHES WERE THEN MANUALLY INSERTED. AFTER AN ATTEMPTED REDUCTION, A STEM 11 IMPLANT WAS INS
Patient problems: Limb Fracture
MAUDE report 11946646 ↗MalfunctionNov 5, 2020Fire; Fire
IT WAS REPORTED FROM (B)(6) THAT THE UNIVERSAL BATTERY CHARGER DEVICE SHOWED FUMES AND SPARKS WHILE CHARGING THE BATTERY DEVICES. 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 Consequences Or Impact To Patient
MAUDE report 10796132 ↗MalfunctionSep 10, 2020Fire; Fire
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT DURING THE CHARGING FUNCTION TEST THE UNIT SPARKED AND TURNED OFF WITH A BURN SMELL EMITTING FROM THE REAR OF THE CHARGER. IT WAS FURTHER DETERMINED THAT THE DEVICE POWER SUPPLY WAS DAMAGED AND THE DEVICE WOULD NOT RUN, THERE WAS A BLOWN FUSE, AND THE DEVICE WAS DEFORMED/BENT, THERE WAS COMPONENT DAMAGE AND THE DEVICE DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK SOFTWARE REVISION, GENERAL CONDITION, POWER-ON TEST, AND CHARGING FUNCTION WITH POWER MODULE/BATTERIES. 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, 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 10514848 ↗MalfunctionFeb 13, 2020Fire; Fire
IT WAS REPORTED FROM (B)(6) THAT PRIOR TO A SURGICAL PROCEDURE FOR A LOWER LEG BONE SHAFT FRACTURE, WHILE IN THE CENTRAL SUPPLY ROOM, IT WAS OBSERVED THAT THE BATTERY CHARGER DEVICE PRODUCED A BLUE SPARK WHEN THE POWER MODULE DEVICE WAS PLUGGED INTO THE CHARGER DEVICE. IT WAS REPORTED THAT THE CHARGER DEVICE THEN GENERATED WHITE SMOKE AND A BURNT SMELL. IT WAS REPORTED THAT THE STAFF WAITED FOR A WHILE, BUT THE DEVICE KEPT GENERATING THE WHITE SMOKE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE POWER MODULE HAD BEEN CHARGED ENOUGH AND COULD BE USED IN THE SURGERY WITHOUT PROBLEMS. 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 9707763 ↗MalfunctionNov 23, 2019Fire; Fire
IT WAS REPORTED FROM (B)(6) THAT THE BATTERY CHARGER DEVICE GENERATED SMOKE, FIRE AND HAD AN ABNORMAL ODOR FOR AN UNKNOWN REASON. 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 THE 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 9366851 ↗MalfunctionNov 11, 2019Premature Separation; Premature Separation
REPORT 1 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT THE LID ¿COVER¿ DEVICE CAME OFF EVEN WHEN THE BATTERY HANDPIECE/MODULAR DEVICE WAS IN LOCKED POSITION. IT WAS FURTHER REPORTED THAT THE COVER WAS REMOVED EVEN WHEN THE BATTERY COVER WAS LOCKED. 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. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9305540 ↗MalfunctionDec 6, 2017Overheating of Device; Overheating of Device
IT WAS REPORTED FROM (B)(6) THAT THE UNIVERSAL BATTERY CHARGER DEVICE OVERHEATED. 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. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7088205 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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