CONNECTING TUBE MAJ-1503Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170233951), received between Jan 20, 2022 and Jan 10, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE CLEANING THE GASTROINTESTINAL VIDEOSCOPE WITH THE ENDOSCOPE REPROCESSOR, THE ENDOSCOPE REPROCESSOR STARTED MAKING STRANGE NOISES. AFTER A WHILE, IT WAS NOTICED THAT THE CLEANING TUBE NEAR THE CONNECTOR ON THE WASHER SIDE WAS CUT. THEREFORE, THE ENDOSCOPE MAY HAVE BEEN INSUFFICIENTLY CLEANED. IT WAS UNCLEAR WHEN THE IRRIGATION TUBE BROKE, SO THERE WAS A POSSIBILITY THAT MULTIPLE ENDOSCOPES HAD BEEN INSUFFICIENTLY CLEANED. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485765 ↗
• MalfunctionJan 20, 2022Device Reprocessing Problem; Device Contamination with Chemical or Other Material; Device Reprocessing Problem; Device Contamination with Chemical or Other Material

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE FIELD SERVICE ENGINEER OF OLYMPUS THAT IT WAS FOUND SOMETHING LIKE WATER STAIN AT THE TIP OF THE INSERTION PART OF THE ENDOSCOPE (GIF-2TQ260M) WHEN IT WAS CONDUCTED THE PERIODIC INSPECTION AT THE USER FACILITY. THIS INDICATED THAT THE USER MAY HAVE USED THE POOR REPROCESSING SUBJECT DEVICE FOR NEXT PROCEDURE. THE USER USES AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-4 AFTER BRUSHING. IN ADDITION, THE USER ALSO INFORMED AND CONCERNED AS FOLLOWINGS; SINCE THERE WERE NO ABNORMALITIES WITH OTHER ENDOSCOPES, IT WAS SAID THAT THERE WAS NO PROBLEM WITH BRUSHING AND CLEANING PROCEDURES. -THE USER CONCERNED THAT THE OWNED CONNECTING TUBES (MAJ-1500, MAJ-1503/THE SUBJECT DEVICE, MAJ-1971) CONNECTED TO THE WASHER MAY BE RELATED TO THIS PHENOMENON THAT THEY FLOAT DURING CLEANING. THERE WAS NO ABNORMALITY IN THE APPEARANCE OF THE TUBE DURING CLEANING, BUT IT FLOATED DURING CLEANING. THERE WAS CONCERN THAT THE CONNECTING TUBE MAY HAVE BECOME SHORTER DUE TO DETERIORATION OF DIRECT SUNLIGHT, THE CLAWS OF THE CLEANING TUBE MAY HAVE BECOME WORSE, OR THERE MAY HAVE BEEN SOME INITIAL FAILURE. THERE WAS NO REPORT OF PATIENT INJURY ASSO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13301231 ↗