EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS TGF-UC180J (UDI 04953170328480)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170328480), received between Jan 19, 2023 and Dec 28, 2023 — classified as 2 injuries, 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0345-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionDec 28, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE ULTRASOUND GASTROVIDEOSCOPE HAD A DAMAGED DISTAL TIP AND THE PROBE ITSELF WAS CHIPPED. THE DAMAGE OF THE SCOPE WAS SEEN DURING REGULAR INSPECTION OF EXPIRED SHELF LIFE SCOPES. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415957 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED, "ENDOSCOPIC ULTRASOUND-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT CORRELATES WITH HISTOLOGICAL HEPATIC FIBROSIS". BACKGROUND AND AIMS: ENDOSCOPIC ULTRASOUND IS A NOVEL DIAGNOSTIC APPROACH TO CHRONIC LIVER DISEASES (CLDS), AND EUS-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT (EUS-PPG) IS AN IMPORTANT EXPANSION WITH A WELL-DEVELOPED TECHNIQUE. HOWEVER, THE CLINICAL VALUE AND APPLICABILITY OF EUS-PPG MEASUREMENT IN PREDICTING HISTOLOGICALLY ADVANCED HEPATIC FIBROSIS REMAIN UNKNOWN. METHODS: THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY ON PATIENTS WITH VARIOUS CLDS UNDERGOING EUS-PPG AND EUS-GUIDED LIVER BIOPSY (EUS-BX) TO ASSESS IF EUS-PPG MEASUREMENTS CORRELATE WITH HISTOLOGICAL FIBROSIS STAGE AND VARIOUS SURROGATE MARKERS FOR SEVERITY OF CLDS AND ITS SAFETY. CASES WITH EUS-PPG WERE IDENTIFIED AT THE UNIVERSITY OF CALIFORNIA IRVINE, A TERTIARY ENDOSCOPY CENTER, BETWEEN JANUARY 2014 AND MARCH 2020. RESULTS: IN 64 PATIENTS, THE MEAN AGE WAS 57.5; 40 (62.5%), MALES; MEAN CHILD-TURCOTTE-PUGH (CTP) AND MODEL FOR END-STAGE LIVER DISEASE (MELD) SCORES, 5.9 AND 10.4, RESPECTIVELY. THE PROCEDURE SUCCESS RATE WA

  Patient problems: Biliary Cirrhosis; Thrombocytopenia

  MAUDE report 16212254 ↗
• InjuryJan 19, 2023Insufficient Device Problem Information

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED, "ENDOSCOPIC ULTRASOUND-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT CORRELATES WITH HISTOLOGICAL HEPATIC FIBROSIS." BACKGROUND AND AIMS: ENDOSCOPIC ULTRASOUND IS A NOVEL DIAGNOSTIC APPROACH TO CHRONIC LIVER DISEASES (CLDS), AND EUS-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT (EUS-PPG) IS AN IMPORTANT EXPANSION WITH A WELL-DEVELOPED TECHNIQUE. HOWEVER, THE CLINICAL VALUE AND APPLICABILITY OF EUS-PPG MEASUREMENT IN PREDICTING HISTOLOGICALLY ADVANCED HEPATIC FIBROSIS REMAIN UNKNOWN. METHODS: THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY ON PATIENTS WITH VARIOUS CLDS UNDERGOING EUS-PPG AND EUS-GUIDED LIVER BIOPSY (EUS-BX) TO ASSESS IF EUS-PPG MEASUREMENTS CORRELATE WITH HISTOLOGICAL FIBROSIS STAGE AND VARIOUS SURROGATE MARKERS FOR SEVERITY OF CLDS AND ITS SAFETY. CASES WITH EUS-PPG WERE IDENTIFIED AT (B)(6), A TERTIARY ENDOSCOPY CENTER, BETWEEN JANUARY 2014 AND MARCH 2020. RESULTS IN 64 PATIENTS, THE MEAN AGE WAS 57.5; 40 (62.5%), MALES; MEAN CHILD-TURCOTTE-PUGH (CTP) AND MODEL FOR END-STAGE LIVER DISEASE (MELD) SCORES, 5.9 AND 10.4, RESPECTIVELY. THE PROCEDURE SUCCESS RATE WAS 100%. TWENTY-NINE (45.3%) HA

  Patient problems: Insufficient Information

  MAUDE report 16212158 ↗