CORE 5400010058Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04546540618238), received between Oct 29, 2018 and Aug 28, 2019 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2019Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE BENT WHILE IT WAS BEING TESTED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8941048 ↗
• MalfunctionAug 28, 2019Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE BENT WHILE IT WAS BEING TESTED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8941044 ↗
• MalfunctionAug 28, 2019Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE BENT WHILE IT WAS BEING TESTED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8941038 ↗
• MalfunctionAug 28, 2019Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE BENT WHILE IT WAS BEING TESTED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8941035 ↗
• MalfunctionAug 28, 2019Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE BENT WHILE IT WAS BEING TESTED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8940949 ↗
• MalfunctionJun 27, 2019Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE BENT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8741254 ↗
• MalfunctionJun 27, 2019Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE BENT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8741252 ↗
• MalfunctionJun 17, 2019Overheating of Device; Overheating of Device

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8704757 ↗
• MalfunctionJun 14, 2019Overheating of Device; Overheating of Device

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8700604 ↗
• MalfunctionJun 14, 2019Overheating of Device; Overheating of Device

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8700602 ↗
• MalfunctionJun 14, 2019Overheating of Device; Overheating of Device

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8700601 ↗
• MalfunctionOct 29, 2018Break; 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 8014635 ↗