NA 0400800000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540152626), received between Jul 9, 2018 and Jul 23, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD MATERIAL THAT WAS SPLIT, CUT, OR TORN DUE TO EXTERNAL OR INTERNAL FORCES. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816151 ↗
• MalfunctionApr 24, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8545823 ↗
• MalfunctionJan 29, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8284711 ↗
• MalfunctionSep 28, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, A WHITE MATERIAL WAS FOUND ON THE HOOD. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7919327 ↗
• MalfunctionAug 13, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND, NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7778930 ↗
• MalfunctionAug 3, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, A FOREIGN MATERIAL WAS FOUND ON THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7747927 ↗
• MalfunctionJul 20, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, A TAPED BUG WAS FOUND IN THE STERILE PACKAGING OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7707011 ↗
• MalfunctionJul 9, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING OF THE PRODUCT. THERE WAS NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7670984 ↗