CONNECTING TUBE MAJ-1971Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170329623), received between Jun 1, 2020 and May 2, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED THAT THE YELLOW CONNECTOR OF THE CONNECTING TUBE WAS FOUND BROKEN DURING THE PREVENTIVE MAINTENANCE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230160 ↗
• MalfunctionAug 2, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), DURING THE REPROCESSING, THE YELLOW CONNECTING TUBE WAS NOTED TO BE BROKEN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442334 ↗
• MalfunctionApr 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE CONNECTING TUBE COULD NOT BE CONNECTED TO THE CHANNEL CONNECTOR AND IT BROKE OFF DUE TO WEAR AND TEAR. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704247 ↗
• MalfunctionNov 23, 2022Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE OER-4 AUTOMATIC ENDOSCOPE REPROCESSOR (AER) AND CONNECTING TUBE WERE USED TO WASH A SCOPE. WHEN WASHING THE SCOPE, THE CONNECTING TUBE WAS CLOGGED AND IT WAS POSSIBLE THAT THE AUXILIARY WATER PIPE AND CHANNEL COULD NOT BE WASHED. IT WAS UNKNOWN IF THE INSUFFICIENTLY CLEANED SCOPE WAS USED ON A PATIENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. THE CLOGGING WAS RESOLVED AND THE SCOPE WAS CLEANED AGAIN WITHOUT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851468 ↗
• 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, MAJ-1971/THE SUBJECT DEVICE) 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 ASSOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13301396 ↗
• MalfunctionOct 30, 2020Device Reprocessing Problem; Device Reprocessing Problem

  DURING THE PREPARATION FOR USE, THE USER FOUND THAT THERE WAS A WHITE FOREIGN MATERIAL IN THE TUBE OF THE PRODUCT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10761392 ↗
• MalfunctionJun 1, 2020Break; Break

  IT WAS REPORTED THAT DURING REPROCESSING THE PLASTIC CONNECTOR ON THE SCOPE WASHER ACCESSORY CABLE WAS FOUND TO BE BROKEN. NO HARM WAS CAUSED BY THIS ISSUE AND THE BROKEN CONNECTOR WAS NOT USED ONCE IT WAS FOUND THE TAB WAS BROKEN.

  Patient problems: No Patient Involvement

  MAUDE report 10105960 ↗