DIEGO ELITE TS101DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821925038820), received between Jan 6, 2026 and Mar 17, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (4 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Packaging Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619029 ↗
• MalfunctionFeb 13, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE DIEGO ELITE TUBESET DECLOG HAD BROWN OILY FLUID ON THE VALVE TO THE BALLOON.THE ISSUE OCCURRED DURING THE DEVICE'S SETUP ¿ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334948 ↗
• MalfunctionFeb 12, 2026Manufacturing, Packaging or Shipping Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321319 ↗
• MalfunctionJan 6, 2026Manufacturing, Packaging or Shipping Problem

  NO ADDITIONAL INFORMATION FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974205 ↗
• MalfunctionJan 6, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE DIEGO ELITE TUBESET DECLOG HAD STAINING/RESIDUE INSIDE THE STERILE PACKAGING. THE ISSUE OCCURRED DURING THE DEVICE'S SETUP ¿ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974198 ↗

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-1181-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
• Z-1180-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
• Z-1182-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
• Z-1179-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
• Z-1187-2019 · Mar 8, 2019 · Terminated
  Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
• Z-1183-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
• Z-1178-2019 · Mar 8, 2019 · Terminated
  Olympus Diego Elite Console MDCONS 100
• Z-1185-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
• Z-1184-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
• Z-1186-2019 · Mar 8, 2019 · Terminated
  Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
• 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