DIEGO ELITE BB2000SARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925038127), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 injury.

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.

• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED BY THE PLAINTIFF'S LAW FIRM, THERE WAS A COMPLICATION REPORTED DURING A PROCEDURE INVOLVING THE SUBJECT DEVICE. THE COMPLICATION WAS REPORTED AS INADVERTENT ENTRY INTO THE ORBIT AT THE LATERAL ASPECT OF THE FRONTAL RECESS ON THE LEFT. THE PROCEDURES PERFORMED DURING THE SURGERY WERE, BILATERAL ENDOSCOPIC: FRONTAL SINUSOTOMY WITH EXPLORATION, TOTAL ETHMOIDECTOMY, MAXILLARY ANTROSTOMY WITH REMOVAL OF TISSUE, SPHENOIDOTOMY WITH REMOVAL OF TISSUE; NASAL SEPTOPLASTY, BILATERAL SUBMUCOSAL RESECTION OF INFERIOR TURBINATES AND USE OF NON-OLYMPUS STEREOTACTIC CT NAVIGATION. THE COMPLICATIONS OF THE PROCEDURE WERE: INADVERTENT ENTRY INTO THE ORBIT AT THE LATERAL ASPECT OF THE FRONTAL RECESS ON THE LEFT. PREOPERATIVE IMAGING SHOWED PREOPERATIVE DEFECT IN THE LAMINA PAPYRACEA AT THIS SITE CONSISTENT WITH PRIOR ORBITAL TRAUMA. A SMALL PIECE OF ORBITAL FAT WAS PROTRUDING THROUGH THIS DEFECT. NO EVIDENCE OF ORBITAL HEMATOMA WAS IDENTIFIED THROUGHOUT THE ENTIRE CASE. THE SMALL DEFECT WAS LEFT OPEN. NO CAUTERY WAS USED OR FURTHER TRAUMA TO THE ORBIT AFTER IDENTIFICATION. ESTIMATED BLOOD LOSS: 100 ML. THE SURGERY FINDINGS INCLUDED: COPIOUS PURULENCE WITHIN THE LEFT MAXILLARY SIN

  Patient problems: Eye Injury

  MAUDE report 15739773 ↗

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-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-1185-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
• 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-1181-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
• Z-1184-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
• 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-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
• 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