NA 05.001.241Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982130167), received between Feb 1, 2018 and Jul 17, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE LID DEVICE HAD AN UNINTENDED/UNEXPECTED DISENGAGEMENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION OF MODE SWITCH LEVER. 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 22530872 ↗
• MalfunctionFeb 14, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED FROM GERMANY THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE LID FOR RECON SAGITTAL SAW DEVICE MOVING PARTS DID NOT MOVE SMOOTHLY, THE MODE SWITCH WAS STUCK, FAILED LEAK TIGHTNESS TEST AND RUN IN THE LOCKED POSITION. THE DEVICE ALSO FAILED PRETESTS FOR LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FUNCTION OF MODE SWITCH LEVER, CHECK THE MODE SWITCH LOCKING FUNCTION WITHOUT HANDPIECE, CHECK TORQUE OF MODE SWITCH LEVER, CHECK THE MODE SWITCH LOCKING FUNCTION WITH HANDPIECE, CHECK THE LID LOCKING FUNCTION WITH HANDPIECE AND CHECK IN ¿LOCK¿ MODE. 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 18705408 ↗
• MalfunctionMay 5, 2021Fail-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 LID RECON SAGITTAL SAW DEVICE LOCKING MECHANISM DID NOT FUNCTION, HAD COMPONENT DAMAGE, RAN IN LOCKED POSITION AND THE HOUSING WAS WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE LID LOCKING FUNCTION WITH HANDPIECE, CHECK THE MODE SWITCH LOCKING FUNCTION WITH HANDPIECE, CHECK THE MODE SWITCH LOCKING FUNCTION WITHOUT HANDPIECE AND GENERAL CONDITION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 11776784 ↗
• MalfunctionDec 16, 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 LID DEVICE LOCKING MECHANISM DID NOT FUNCTION, THE DEVICE RAN IN THE LOCKED POSITION AND LOCKING MECHANISM WAS STIFF/STUCK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK IN THE LOCK POSITION, CHECK THE LID LOCKING FUNCTION WITH THE HANDPIECE, CHECK THE MODE SWITCH LOCKING FUNCTION WITH THE HANDPIECE AND CHECK THE MODE SWITCH LOCKING FUNCTION WITHOUT HANDPIECE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. 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 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 11022874 ↗
• MalfunctionOct 12, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID DEVICE RAN IN LOCKED POSITION AND HAD A COMPONENT DAMAGE. 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 DID NOT WORK. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10667901 ↗
• MalfunctionFeb 1, 2018Unintended System Motion; Fail-Safe Problem; Unintended System Motion; Fail-Safe Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LOCKING MECHANISM WAS DEFECTIVE ON THE LID DEVICE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION ¿LOCK/UNLOCK¿ WITH SAFETY BUTTON, CHECK THE LOCKING FUNCTION WITH HANDPIECE AND CHECK THE FUNCTION WITH POWER MODULE AND HANDPIECE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. 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 THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7234874 ↗