EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS TGF-UC180J (UDI 04953170355493)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170355493), received between Jun 2, 2022 and Jan 8, 2026 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE GASTROVIDEOSCOPE WAS DETACHED FROM THE DISTAL END SIDE DUE TO MISSING SEALANT, AND THERE WAS MISSING SEALANT AT THE EDGE OF THE PINK RUBBER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004253 ↗
• MalfunctionAug 21, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED THAT THE ULTRASOUND GASTROVIDEOSCOPE HAD AN AIR/WATER LEAK AND WAS FAILING REPROCESSING. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: FOREIGN MATTER CAME OUT OF THE NOZZLE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584475 ↗
• MalfunctionJul 25, 2022Contamination; Contamination

  THE DEVICE WAS RETURNED BY THE CUSTOMER FOR EVALUATION AND REPAIR FOR THE ISSUE OF CHANNEL PORT NOT FUNCTIONING PROPERLY AS OBSERVED DURING REPROCESSING. THERE IS NO HARM REPORTED TO ANY PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THERE WAS PRESENCE OF FOREIGN OBJECT IN THE FORCEPS PASSAGE. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE FOREIGN MATERIAL FOUND IN THE FORCEPS PASSAGE AS OBSERVED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15095321 ↗
• MalfunctionJul 21, 2022Peeled/Delaminated; Peeled/Delaminated

  THIS IS A LOANER DEVICE RETURNED BY A CUSTOMER. UPON INSPECTION, IT WAS OBSERVED THAT THE ULTRASOUND PROBE LENS WAS PEELED WITH A MISSING PIECE. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15079493 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED:¿ ENDOSCOPIC INTERNAL DRAINAGE OF COMPLEX BILOMAS AND BILIARY LEAKS BY TRANSMURAL OR TRANSPAPILLARY/TRANSFISTULARY ACCESS,¿ PATIENT EXPERIENCED ADVERSE EVENTS DURING AND AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GF-UCT140-AL5 (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GF-UCT140-AL5(FOR ADVERSE EVENTS OTHER THAN DEATH). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TGF-UC180J (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TGF-UC180J (FOR ADVERSE EVENTS OTHER THAN DEATH). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-160VR (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-160VR (FOR ADVERSE EVENTS OTHER THAN DEATH). CASE WITH PATIENT IDENTIFIER C22182246 REPORTS TJF-Q180V (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER C22182247 REPORTS TJF-Q180V (FOR ADVERSE EVENTS OTHER THAN DEATH). STUDY BACKGROUND AND AIM: BILOMAS MOST FREQUENTLY RESULT FROM POSTOPERATIVE BILE LEAKS. THE ENDOSCOPIC CONVENTIONAL TREATMENT IS SPHINCTEROTOMY STENT PLACEMENT. IN COMPLEX CASES, SUCH AS ALTERED ANATOMY OR FAILURE OF CONVENTIONAL TREATMENT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Septic Shock; Unspecified Hepatic or Biliary Problem

  MAUDE report 14578240 ↗
• DeathJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED:¿ ENDOSCOPIC INTERNAL DRAINAGE OF COMPLEX BILOMAS AND BILIARY LEAKS BY TRANSMURAL OR TRANSPAPILLARY/TRANSFISTULARY ACCESS,¿ PATIENT EXPERIENCED ADVERSE EVENTS DURING AND AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GF-UCT140-AL5 (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GF-UCT140-AL5(FOR ADVERSE EVENTS OTHER THAN DEATH). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TGF-UC180J (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TGF-UC180J (FOR ADVERSE EVENTS OTHER THAN DEATH). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-160VR (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-160VR (FOR ADVERSE EVENTS OTHER THAN DEATH). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-Q180V (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-Q180V (FOR ADVERSE EVENTS OTHER THAN DEATH). STUDY BACKGROUND AND AIM: BILOMAS MOST FREQUENTLY RESULT FROM POSTOPERATIVE BILE LEAKS. THE ENDOSCOPIC CONVENTIONAL TREATMENT IS SPHINCTEROTOMY STENT PLACEMENT. IN COMPLEX CASES, SUCH AS ALTERED ANATOMY OR FAILURE OF CONVENTIONAL TREATMENT, TRAN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Septic Shock

  MAUDE report 14578194 ↗