ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5 (UDI 04953170355448)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170355448), received between Oct 2, 2020 and May 3, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT IS REPORTED IN THE LITERATURE TITLED "RISK OF INFECTION TRANSMISSION IN CURVILINEAR ARRAY ECHOENDOSCOPES: RESULTS OF A PROSPECTIVE PROCESSING AND CULTURE REGISTRY", 22/540 CULTURES OF LINEAR ENDOSCOPIC ULTRASOUND (EUS) (4,2%) WERE POSITIVE FOR GRAM-NEGATIVE BACILLI AFTER CLEANING AND HIGH LEVEL DISINFECTION (HLD). BEGINNING IN FEBRUARY 2015 TO FEBRUARY 2016, CURVILINEAR ARRAY (CLA) ECHOENDOSCOPES AT A SINGLE TERTIARY CARE CENTER UNDERWENT PROSPECTIVE BACTERIAL SURVEILLANCE CULTURES AFTER REPROCESSING. ANY GROWTH OF GRAM-NEGATIVE BACILLI WAS CONSIDERED TO BE CRITICAL. ECHOENDOSCOPES WITH A POSITIVE RESULT UNDERWENT QUARANTINE FOLLOWED BY REPEAT DISINFECTION AND CULTURE. DURING THE STUDY PERIOD, 540 CULTURES WERE OBTAINED; 521 (96.5%) WERE PRIMARY CULTURES OBTAINED FROM 18 CLA ECHOENDOSCOPES. TWENTY-TWO PRIMARY CULTURES (4.2%) WERE POSITIVE FOR GRAM-NEGATIVE BACILLI AFTER HIGH-LEVEL DISINFECTION REPROCESSING. ELEVEN DIFFERENT BACTERIA WERE ISOLATED: KLEBSIELLA PNEUMONIAE, CITROBACTER FREUNDII, ESCHERICHIA COLI, PSEUDOMONAS AERUGINOSA, KLEBSIELLA OXYTOCA, SPHINGOMONAS PAUCIMOBILIS, ACINETOBACTER BAUMANII, ENTEROBACTER CLOACAE, HAFNIA ALVEI, PSEUDOMONAS PUTIDA, AND STENOTROPHOMONAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760617 ↗
• MalfunctionJan 2, 2021Break; Break

  DURING A STANDARD SERVICE INSPECTION, THE ULTRASONIC GASTRO-VIDEOSCOPE WAS FOUND TO HAVE A CRACKED PROBE UNIT AT THE DISTAL END. NO PATIENT INVOLVEMENT WAS REPORTED AS THE SCOPE IS USED FOR VALIDATION TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 11103624 ↗
• MalfunctionOct 2, 2020Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT THE SCOPE HAS BENDING MANIPULATION, AND INSERTION TUBE DEFECTS. THE ANGULATION LOCKING MECHANISM IS NOT LOCKING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10619715 ↗