Suction Valve MD-493 (REF GX0366)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170064104), received between Jul 24, 2023 and Jul 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SUCTION VALVES WERE CONTAMINATED WITH STENOTROPHOMONAS MALTOPHILIA BACTERIA THAT OCCURRED DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT INFECTION. ACCORDING TO THE REPORT, THE CONTAMINATION OCCURRED WHEN INADEQUATE REPROCESSING PROCEDURES WERE FOLLOWED. NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THIS EVENT. THIS EVENT REPORTED INVOLVED SEVEN SUCTION VALVES. THE SEVEN (7) SUCTION VALVE INVOLVED IN THIS EVENT (BACTERIAL CONTAMINATION) ARE REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385962 ↗
• MalfunctionJul 24, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device

  THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED TO THIS EVENT: (B)(6), MD-493: SUCTION VALVE -1. (B)(6), MD-493: SUCTION VALVE -2. (B)(6), MD-493: SUCTION VALVE -3. (B)(6), MD-493: SUCTION VALVE -4. (B)(6), MD-493: SUCTION VALVE -5. (B)(6), MD-493: SUCTION VALVE -6. (B)(6), MD-493: SUCTION VALVE -7. (B)(6), LF-TP, SN (B)(6). (B)(6), LF-GP, SN (B)(6). (B)(6), LF-GP, SN (B)(6). (B)(6), LF-TP, SN (B)(6). (B)(6), LF-GP, SN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379416 ↗