NA 05.001.083Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886982129048), received between Sep 15, 2020 and Nov 18, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE AIR PEN DRIVE DEVICE MOTOR, THE HOSE BURST AT THE POINT WHERE IT CONNECTS TO THE HANDPIECE. TO PROVIDE A PROMPT SOLUTION, A COMPETITOR¿S MOTOR WAS IMMEDIATELY GIVEN TO THE SPECIALIST, ALLOWING THE SURGERY TO BE SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. 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 23585747 ↗
• MalfunctionOct 17, 2025Break; Leak/Splash; Noise, Audible; Break; Leak/Splash; Noise, Audible

  IT WAS REPORTED THAT THE DOUBLE AIR HOSE, 3M, FOR AIR PEN DRIVE DEVICE HAD A LEAKAGE NOISE WHEN CONNECTING THE HOSE TO NITROGEN. MOTOR DEVICE OVERHEATED. IT WAS REPORTED THAT IT SEEMED TO BE BY A RUPTURE OR FAILURE OF THE INTERNAL HOSE TO THE COUPLING ON THE END OF IT. 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." ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325283 ↗
• MalfunctionJul 9, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DOUBLE AIR HOSE DEVICE ¿BURSTS¿. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A TEN-MINUTE DELAY TO THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460969 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHILE USING THE TRUESPAN 24 DEGREE PLGA DEVICE ENGINE THE HOSE BURST WHICH CAUSED DISCOMFORT IN THE SPECIALIST. THERE WAS A TWENTY MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION WAS STABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971734 ↗
• MalfunctionMar 27, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE MOTOR OF AIR PEN DRIVE DEVICE STOPPED WORKING THE HOSE OF THE DEVICE SUFFERED INTERNAL RUPTURE BECAUSE IT DID NOT PASS NITROGEN TO THE HANDPIECE. IT WAS REPORTED THAT THERE WAS A DELAY TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE THE 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 21709187 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE AIR HOSE DEVICE RUPTURED. THE REPORTER STATED THAT WHILE CONNECTING AND TESTING THE ENGINE, IT PERFORMED WELL; HOWEVER, WHEN THE SURGEON UTILIZED THE ENGINE IN CONJUNCTION WITH THE SAW DEVICE, THE HOSE BURST. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 21537332 ↗
• MalfunctionMay 8, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE DOUBLE AIR HOSE DEVICE EXPLODED. THE REPORTER EXPLAINED THAT WHEN THE HOSE WAS CONNECTED TO THE PRESSURE GAUGE AND THE CYLINDER WAS OPENED, THE PRESSURE READINGS APPEARED NORMAL, BUT A NOISE WAS HEARD, FOLLOWED BY A SUDDEN SOUND AS IF IT HAD DISCONNECTED DUE TO PRESSURE. IT WAS REALIZED THAT THE INTERNAL HOSE BENEATH THE BLACK COATING HAD EXPLODED, WHICH PREVENTED PRESSURE FROM REACHING THE PIECE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS 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 19269454 ↗
• MalfunctionApr 15, 2024Break; Break

  IT WAS REPORTED FROM COLOMBIA THAT DURING A BREAST SURGERY, IT WAS DISCOVERED THAT THE HOSE DEVICE BURST. IT WAS REPORTED THAT THE MOTOR DEVICE AND THE HOSE DEVICE WERE CONNECTED AS USUAL, AND THEY FUNCTIONED AS EXPECTED. HOWEVER, HALFWAY THROUGH THE SURGERY, THE HOSE SUDDENLY BURST, CAUSING A GREAT DISCOMFORT TO THE SPECIALIST. THE DEVICE WAS TESTED AGAIN, AND IT WORKED, AND SO THE SURGEON DECIDED TO PROCEED WITH THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A FIFTEEN-MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS 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 19109849 ↗
• MalfunctionApr 4, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DOUBLE AIR HOSE DEVICE EXPLODED LEAVING THE COUPLING STUCK IN THE HANDPIECE DEVICE. IT WAS FURTHER OBSERVED THAT THE DEVICE MOTOR WAS UNUSABLE AND THERE WAS NITROGEN LEAKING FROM THE HOSE, THERE WAS A TEN MINUTE DELAY IN THE SURGICAL PROCEDURE. THE FACILITY WAS LOANED A DEVICE TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 19043331 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED FROM COLOMBIA THAT THE AIR HOSE DEVICE BURST. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. 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 18696216 ↗
• MalfunctionFeb 2, 2024Break; Break

  IT WAS REPORTED FROM GERMANY THAT THE DOUBLE AIR HOSE DEVICE HAD BURST. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632496 ↗
• MalfunctionDec 7, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HOSE OF THE AIR HOSE DEVICE WAS RUPTURED. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD AN AIR LEAK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR INTERNAL PRESSURE TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE INNER HOSE CAME OFF. 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. 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 18282268 ↗
• MalfunctionNov 16, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DOUBLE AIR HOSE DEVICE HOSE WAS RUPTURED AND WAS LEAKING AIR, THE INNER HOSE WAS DETACHED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR INTERNAL PRESSURE TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS LEAKING AIR. 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 2023. 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 18148229 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE AIR HOSE DEVICE BURST. 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. 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 18110162 ↗
• MalfunctionNov 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DOUBLE AIR HOSE DEVICE RUPTURED. IT WAS NOTED THAT THE INNER HOSE TORE OFF. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR INTERNAL PRESSURE TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE INNER HOSE HAD COME OFF. 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 18096902 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR HOSE DEVICE WAS RUPTURED. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD A COMPONENT DAMAGE AND AN AIR LEAK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION AND EXTERNAL PRESSURE 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 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003121 ↗
• MalfunctionAug 30, 2023Break; Noise, Audible; Break; Noise, Audible

  IT WAS REPORTED FROM COLOMBIA THAT HALFWAY THROUGH AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DOUBLE HOSE DEVICE WAS MAKING A SOUND AS IF IT HAD AN EXHAUST WHEN THE ENGINE EXPLODED. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT AN UNSPECIFIED SPARE DEVICE WAS AVAILABLE FOR USE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THE HOSE WAS LEFT MARKED WITH RED TAPE AND A CASE REPORT WAS FILED. THERE WAS 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 2023. 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 17651714 ↗
• MalfunctionJul 17, 2023Break; Break

  IT WAS REPORTED THAT DURING EQUIPMENT MAINTENANCE, IT WAS OBSERVED THAT THE AIR HOSE DEVICE WAS USED A FEW TIME AND EACH TIME THE HOSE CURLED UP AS SOON AS PRESSURE WAS APPLIED TO IT. HOWEVER, ON 7/1 THIS WAS SO BAD THAT DEVICE BURST IN THE PROCESS. THIS WAS A VETERINARY EVENT. THERE WAS NO HUMAN 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 17335222 ↗
• MalfunctionJun 21, 2023Break; Break

  IT WAS REPORTED FROM GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DOUBLE AIR HOSE DEVICE RUPTURED, THE ETCHING WAS ILLEGIBLE, AND THE INNER HOSE FROM THE COMPRESSED AIR CONNECTION WAS LOOSE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, AND EXTERNAL PRESSURE 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, 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172903 ↗
• MalfunctionJan 24, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY COLOMBIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HOSE DEVICE RUPTURED. IT WAS DETERMINED THAT THE DEVICE HAD AN AIR LEAK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FOR CORRECTNESS OF SPECIFIC DOUBLE AIR HOSE, CHECK MARKING RINGS, CHECK OUTER HOSE, INTERNAL PRESSURE TEST AND EXTERNAL PRESSURE TEST. IT WAS NOTED IN THE SERVICE ORDER THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE HOSE DID NOT FUNCTION; THEREFORE, THE MOTOR DEVICE COULD NOT BE USED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR 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) 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 16233194 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HOSE OF THE DOUBLE AIR HOSE DEVICE WAS RUPTURED. IT WAS DETERMINED THAT THE DEVICE HAD AN AIR LEAK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK OUTER HOSE AND EXTERNAL PRESSURE 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 UNKNOWN. 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 15390824 ↗
• MalfunctionAug 19, 2022Material Rupture; Device-Device Incompatibility; Material Rupture; Device-Device Incompatibility

  IT WAS REPORTED FROM GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR HOSE DEVICE HOSE RUPTURED, HAD AN AIR LEAK AND FAILED PRE-TEST FOR EXTERNAL PRESSURE TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE PIPE SEPARATES FROM THE NOZZLE. 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 15257798 ↗
• MalfunctionJul 15, 2022Break; Premature Separation; Break; Premature Separation

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE DOUBLE AIR HOSE DEVICE BURST AND ENDED UP UNCOUPLED AT THE END THAT CONNECTS TO THE DRILL. IT WAS REPORTED THAT THERE WAS A FIFTEEN-MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED AS INTENDED. 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 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 15026848 ↗
• MalfunctionMay 13, 2022Break; Break

  IT WAS REPORTED FROM (B)(6) THAT DURING A HAND SURGERY, IT WAS DISCOVERED THAT THE DOUBLE AIR HOSE DEVICE HOSE BURST DURING THE FIRST USE. THERE WAS A FIFTEEN- TWENTY MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY WITHOUT ANY ISSUES. THERE WAS 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 14391454 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DOUBLE HOSE DEVICE BURST AND FAILED DURING THE PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS SPARE DEVICE 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 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 13723180 ↗