DIEGO 70338000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925011441), received between Nov 30, 2023 and Dec 4, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A POST MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY, THE DIEGO ELITE WAS USED FOR AN ADENOIDECTOMY/TONSILLECTOMY. THE DEVICE ADEQUATELY REMOVED SOFT TISSUE DURING THE PROCEDURE, HOWEVER PERIPROCEDURAL BLEEDING OCCURRED THAT REQUIRED ADDITIONAL SURGICAL INTERVENTION. THE PATIENT MADE A FULL RECOVERY TO BASELINE AT TIME OF HOSPITAL DISCHARGE. THERE WERE NO KNOWN PATIENT COMORBIDITIES AT THE TIME OF PROCEDURE THAT MAY HAVE ATTRIBUTED TO THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18263915 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A POST-MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY, THE DIEGO ELITE WAS USED FOR SOFT TISSUE SHAVING OF THE HEAD AND NECK. THE DEVICE ADEQUATELY DRILLED THE SOFT TISSUE. A MUCOSAL INJURY OCCURRED WITHIN 2 TO 7 DAYS POST PROCEDURE THAT REQUIRED A RE-HOSPITALIZATION. THE PATIENT MADE A PARTIAL RECOVERY TO BASELINE. THERE WERE NO KNOWN CO-MORBIDITIES THAT MAY HAVE ATTRIBUTED TO THE MUCOSAL INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18243745 ↗