DIEGO ELITE BB4040SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925040564), received between Sep 18, 2022 and Sep 18, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

12 other recalls cover devices cleared under the same FDA submission (K123429); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2022Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  IT WAS REPORTED DURING REMOVAL OF POLYPS IN THE PARANASAL SINUS PROCEDURE , WHITE INSULATION ON SHAVER BLADE HAS COME LOOSE AND IS HALF TORN AND FOLDED OVER DURING SURGERY. REPORTER STATED THAT HE WAS AT THE SURGERY AND WAS THE FIRST TO NOTICE. ACCORDING TO THE REPORTER, IT COULD NOT BE SEEN THAT THE SURGEON HAD CAUSED IT WITH A SHARP INSTRUMENT. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS DISPOSED OF BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443471 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123429. One submission often covers many models, so check the product and lot details in each record.

• Z-1179-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
• Z-1181-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
• Z-1183-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
• Z-1182-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
• Z-1187-2019 · Mar 8, 2019 · Terminated
  Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
• Z-1180-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
• Z-1178-2019 · Mar 8, 2019 · Terminated
  Olympus Diego Elite Console MDCONS 100
• Z-1186-2019 · Mar 8, 2019 · Terminated
  Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
• Z-1184-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
• Z-1185-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
• Z-1753-2015 · May 8, 2015 · Terminated
  Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngea
• Z-1752-2015 · May 8, 2015 · Terminated
  Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngea