NA 6208000000Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07613154392711), received between Jul 24, 2018 and Jan 22, 2024 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556972 ↗
• MalfunctionOct 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987293 ↗
• MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807592 ↗
• MalfunctionApr 24, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A STICKY SAFETY DEVICE THAT COULD LEAD TO UNINTENDED POWER-UP. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802899 ↗
• MalfunctionJan 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261872 ↗
• MalfunctionJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102082 ↗
• MalfunctionJul 26, 2022Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD UNINTENDED SYSTEM MOTION. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101959 ↗
• MalfunctionOct 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715393 ↗
• MalfunctionOct 22, 2021Fail-Safe Problem; Fail-Safe Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12680278 ↗
• MalfunctionJul 27, 2021Fracture; Fracture

  IT WAS REPORTED DURING A PROCEDURE THAT THE SAW BLADE BROKE. THE PROCEDURE WAS COMPLETELY SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE CONSEQUENCES WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231619 ↗
• MalfunctionApr 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728978 ↗
• MalfunctionOct 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10749181 ↗
• MalfunctionJan 28, 2020Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9637322 ↗
• MalfunctionJan 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9637318 ↗
• MalfunctionJan 28, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9637309 ↗
• MalfunctionOct 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9244433 ↗
• MalfunctionOct 28, 2019Unintended Power Up; Unintended Power Up

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9244429 ↗
• MalfunctionJul 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816599 ↗
• MalfunctionJul 23, 2019Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES NOE 2 /NOE MALFUNCTION EVENTS IN WHICH THE DEVICE HAD RUN-ON. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8816594 ↗
• MalfunctionJul 23, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8816444 ↗
• MalfunctionApr 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546361 ↗
• MalfunctionApr 24, 2019Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD RUN-ON. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8546001 ↗
• MalfunctionJan 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285204 ↗
• MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES <NOE> 8 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD NO KNOWN PATIENT INVOLVEMENT OR PATIENT IMPACT. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8285056 ↗
• MalfunctionJan 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 1 EVENT HAD NO KNOWN PATIENT INVOLVEMENT OR PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8284896 ↗