NA 6001-088-327Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540350848), received between Feb 16, 2017 and Aug 10, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE TIP BENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301151 ↗
• MalfunctionAug 20, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE DEVICE'S TIP BROKE OFF DURING STERILIZATION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING STERILIZATION AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8912769 ↗
• MalfunctionApr 29, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560137 ↗
• MalfunctionFeb 25, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY, IT WAS OBSERVED THAT THE TIP BROKE OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8366562 ↗
• MalfunctionFeb 25, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY, IT WAS OBSERVED THAT THE TIP BROKE OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8366557 ↗
• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED THAT AT THE USER FACILITY IN THE STERILE PROCESSING DEPARTMENT THE DEVICE WAS FOUND WITH THE A BROKEN TIP. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT DID NOT OCCUR DURING A PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357927 ↗
• MalfunctionJan 15, 2019Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8250718 ↗
• MalfunctionJan 4, 2019Break; Break

  IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE WAS FOUND WITH THE SUCTION END BROKE IN TWO. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT DID NOT OCCUR DURING A PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8217549 ↗
• MalfunctionNov 14, 2018Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP OF THE DEVICE WAS BROKEN OFF. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8071786 ↗
• MalfunctionSep 24, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE CAMERA LENS ON THE INSTRUMENT WAS FOUND BROKEN OFF DURING SET UP FOR A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7903148 ↗
• MalfunctionApr 12, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE TIP OF THE DEVICE BROKE OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE REPORTED TO HAVE BEEN ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6486731 ↗
• MalfunctionMar 14, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE BLACK LED COVER FELL OFF THE DEVICE. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE REPORTED BY THE USER FACILITY WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6404775 ↗
• MalfunctionFeb 16, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE LENS OF THE DEVICE WAS IDENTIFIED TO HAVE BROKEN OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE REPORTED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6335150 ↗