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CONNECTING TUBE MAJ-1500Recalls & reported problems

Olympus Medical Systems Corp. · Class 2

All models of CONNECTING TUBE (23)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Olympus MAJ-1500 connecting tube is used to attach a gastrointestinal endoscope to an Olympus endoscope reprocessor for cleaning and disinfection between patients. The 36 reports describe mechanical trouble with the tube during cleaning — it breaking, coming apart, or detaching from the reprocessor, plus cleaning problems such as residue or chemical contamination. There are 36 malfunctions, no deaths and no injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
36
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 04953170233937), received between Apr 23, 2019 and Jun 3, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem10
  • Break9
  • Device Reprocessing Problem8
  • Detachment of Device or Device Component3
  • Device Contamination with Chemical or Other Material2
  • Improper or Incorrect Procedure or Method2
  • Crack1
  • Failure to Clean Adequately1

Patient problems

  • No Clinical Signs, Symptoms or Conditions24
  • No Known Impact Or Consequence To Patient6
  • No Consequences Or Impact To Patient4
  • No Patient Involvement2

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 3, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE ENDOSCOPE REPROCESSOR (OER-3) WAS USED TO REPROCESS A GASTROINTESTINAL VIDEOSCOPE (GIF-XZ1200) WITHOUT THE CONNECTING TUBE ATTACHED TO THE VIDEOSCOPE AND THE VIDEOSCOPE WAS USED ON THE NEXT PATIENT AS IS. THE ISSUE WAS FOUND DURING REPROCESSING AND THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22137342 ↗
  • MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED, THE CONNECTING TUBE DISASSEMBLED WHEN SLIDING IT TO THE SCOPE.THE ISSUE OCCURRED DURING PREPARATION FOR REPROCESSING. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19358749 ↗
  • MalfunctionApr 26, 2024Break; Break

    IT WAS REPORTED THAT THE GREY CONNECTING TUBE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19198310 ↗
  • MalfunctionMar 25, 2024Break; Break

    IT WAS REPORTED, THE FIXED BUCKLE OF THE CONNECTING TUBE WAS BROKEN. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18968411 ↗
  • MalfunctionFeb 20, 2024Improper or Incorrect Procedure or Method; Misassembly by Users; Improper or Incorrect Procedure or Method; Misassembly by Users

    IT WAS REPORTED, THE CONNECTING TUBE HAD BEEN MODIFIED AND WAS CLEANED WITH NON-REGULAR MATERIALS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18736780 ↗
  • MalfunctionJan 26, 2024Crack; Crack

    THE END-USER FACILITY HAS PROVIDED ADDITIONAL INFORMATION STATING THAT A TOTAL OF 10 PATIENTS WERE IMPACTED BY THE INADEQUATELY REPROCESSED ENDOSCOPES; NOT THE ORIGINALLY REPORTED 20. NONE OF THESE 10 PATIENTS EXPERIENCED ANY ADVERSE HEALTH EFFECTS FROM USE OF THE INADEQUATELY CLEANED ENDOSCOPES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18589286 ↗
  • MalfunctionAug 21, 2023Failure to Clean Adequately; Failure to Clean Adequately

    THE CUSTOMER REPORTED DURING REPROCESSING, THE EQUIPMENT SIDE CONNECTOR WAS DISCONNECTED FROM THE WASHING TUBE OF MAJ-1500. WHEN RECONNECTING THE TUBING BY HAND, THE STOPPER WAS MOVED, BUT THE TUBING WAS HARD TO MOVE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: WHITE FOREIGN MATTER WAS ADHERED TO THE CONNECTOR OF THE CLEANING TUBE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17591921 ↗
  • MalfunctionApr 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), A GRAY CONNECTOR OF A REPROCESSOR CAME OFF IN THE CONNECTING TUBE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. PATIENT IDENTIFIER (B)(6) CAPTURES THE COMPLAINT ON THE ENDOSCOPE REPROCESSOR (MODEL NUMBER: OER-PRO, SERIAL NUMBER: (B)(4)).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16708657 ↗
  • MalfunctionMar 30, 2023Device Reprocessing Problem; Device Reprocessing Problem

    THE CUSTOMER REPORTED, THAT WHEN CLEANING WITH THE ENDOSCOPE REPROCESSOR AND CONNECTING TUBE, CLEANING WAS PERFORMED WITHOUT ATTACHING THE CONNECTOR ON THE ENDOSCOPE SIDE OF THE CLEANING/CONNECTING TUBE (THE MOUTH OF THE TUBE THAT CONNECTED TO THE FORCEPS MOUTH). THE CUSTOMER HAD INQUIRED ABOUT HOW MUCH ACESIDE AND DETERGENT REMAINED AROUND THE FORCEPS OPENING AND IN THE CHANNEL. THE CUSTOMER FURTHER STATED THAT THEY KNEW THE SCOPE WAS NOT DISINFECTED. THEY DIDN'T KNOW HOW LONG CLEANING HAD BEEN DONE LIKE THIS OR WHAT TYPE OF SCOPE WAS CLEANED. IT WAS UNKNOWN IF ANY PATIENT'S HAD BEEN INFECTED. THE SITE HAD RECENT CHANGES IN STAFF AND THE CUSTOMER SUSPECTED THIS MAY HAVE RESULTED IN THE INSUFFICIENT CLEANING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16643019 ↗
  • MalfunctionMar 30, 2023Device Reprocessing Problem; Device Reprocessing Problem

    THE CUSTOMER REPORTED THAT WHEN CLEANING WITH THE ENDOSCOPE REPROCESSOR AND CONNECTING TUBE, CLEANING WAS PERFORMED WITHOUT ATTACHING THE CONNECTOR ON THE ENDOSCOPE SIDE OF THE CLEANING/CONNECTING TUBE (THE MOUTH OF THE TUBE THAT CONNECTED TO THE FORCEPS MOUTH). THE CUSTOMER HAD INQUIRED ABOUT HOW MUCH ACESIDE AND DETERGENT REMAINED AROUND THE FORCEPS OPENING AND IN THE CHANNEL. THE CUSTOMER FURTHER STATED THAT THEY KNEW THE SCOPE WAS NOT DISINFECTED, THEY DIDN'T KNOW HOW LONG CLEANING HAD BEEN DONE LIKE THIS OR WHAT TYPE OF SCOPE WAS CLEANED. IT WAS UNKNOWN IF ANY PATIENT'S HAD BEEN INFECTED. THE SITE HAD RECENT CHANGES IN STAFF AND THE CUSTOMER SUSPECTED THIS MAY HAVE RESULTED IN THE INSUFFICIENT CLEANING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16643015 ↗
  • MalfunctionMar 30, 2023Device Reprocessing Problem; Device Reprocessing Problem

    THE CUSTOMER REPORTED THAT WHEN CLEANING WITH THE ENDOSCOPE REPROCESSOR AND CONNECTING TUBE, CLEANING WAS PERFORMED WITHOUT ATTACHING THE CONNECTOR ON THE ENDOSCOPE SIDE OF THE CLEANING/CONNECTING TUBE (THE MOUTH OF THE TUBE THAT CONNECTED TO THE FORCEPS MOUTH). THE CUSTOMER HAD INQUIRED ABOUT HOW MUCH ACESIDE AND DETERGENT REMAINED AROUND THE FORCEPS OPENING AND IN THE CHANNEL. THE CUSTOMER FURTHER STATED THAT THEY KNEW THE SCOPE WAS NOT DISINFECTED, THEY DIDN'T KNOW HOW LONG CLEANING HAD BEEN DONE LIKE THIS OR WHAT TYPE OF SCOPE WAS CLEANED. IT WAS UNKNOWN IF ANY PATIENT'S HAD BEEN INFECTED. THE SITE HAD RECENT CHANGES IN STAFF AND THE CUSTOMER SUSPECTED THIS MAY HAVE RESULTED IN THE INSUFFICIENT CLEANING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16643011 ↗
  • MalfunctionMar 30, 2023Device Reprocessing Problem; Device Reprocessing Problem

    THE CUSTOMER REPORTED THAT WHEN CLEANING WITH THE ENDOSCOPE REPROCESSOR AND CONNECTING TUBE, CLEANING WAS PERFORMED WITHOUT ATTACHING THE CONNECTOR ON THE ENDOSCOPE SIDE OF THE CLEANING/CONNECTING TUBE (THE MOUTH OF THE TUBE THAT CONNECTED TO THE FORCEPS MOUTH). THE CUSTOMER HAD INQUIRED ABOUT HOW MUCH ACESIDE AND DETERGENT REMAINED AROUND THE FORCEPS OPENING AND IN THE CHANNEL. THE CUSTOMER FURTHER STATED THAT THEY KNEW THE SCOPE WAS NOT DISINFECTED, THEY DIDN'T KNOW HOW LONG CLEANING HAD BEEN DONE LIKE THIS OR WHAT TYPE OF SCOPE WAS CLEANED. IT WAS UNKNOWN IF ANY PATIENT'S HAD BEEN INFECTED. THE SITE HAD RECENT CHANGES IN STAFF AND THE CUSTOMER SUSPECTED THIS MAY HAVE RESULTED IN THE INSUFFICIENT CLEANING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16642984 ↗
  • MalfunctionMar 30, 2023Device Reprocessing Problem; Device Reprocessing Problem

    THE CUSTOMER REPORTED THAT WHEN CLEANING WITH THE ENDOSCOPE REPROCESSOR AND CONNECTING TUBE, CLEANING WAS PERFORMED WITHOUT ATTACHING THE CONNECTOR ON THE ENDOSCOPE SIDE OF THE CLEANING/CONNECTING TUBE (THE MOUTH OF THE TUBE THAT CONNECTED TO THE FORCEPS MOUTH). THE CUSTOMER HAD INQUIRED ABOUT HOW MUCH ACESIDE AND DETERGENT REMAINED AROUND THE FORCEPS OPENING AND IN THE CHANNEL. THE CUSTOMER FURTHER STATED THAT THEY KNEW THE SCOPE WAS NOT DISINFECTED, THEY DIDN'T KNOW HOW LONG CLEANING HAD BEEN DONE LIKE THIS OR WHAT TYPE OF SCOPE WAS CLEANED. IT WAS UNKNOWN IF ANY PATIENT'S HAD BEEN INFECTED. THE SITE HAD RECENT CHANGES IN STAFF AND THE CUSTOMER SUSPECTED THIS MAY HAVE RESULTED IN THE INSUFFICIENT CLEANING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16642975 ↗
  • MalfunctionMar 30, 2023Device Reprocessing Problem; Device Reprocessing Problem

    THE CUSTOMER REPORTED THAT WHEN CLEANING WITH THE ENDOSCOPE REPROCESSOR AND CONNECTING TUBE, CLEANING WAS PERFORMED WITHOUT ATTACHING THE CONNECTOR ON THE ENDOSCOPE SIDE OF THE CLEANING/CONNECTING TUBE (THE MOUTH OF THE TUBE THAT CONNECTED TO THE FORCEPS MOUTH). THE CUSTOMER HAD INQUIRED ABOUT HOW MUCH ACESIDE AND DETERGENT REMAINED AROUND THE FORCEPS OPENING AND IN THE CHANNEL. THE CUSTOMER FURTHER STATED THAT THEY KNEW THE SCOPE WAS NOT DISINFECTED, THEY DIDN'T KNOW HOW LONG CLEANING HAD BEEN DONE LIKE THIS OR WHAT TYPE OF SCOPE WAS CLEANED. IT WAS UNKNOWN IF ANY PATIENT'S HAD BEEN INFECTED. THE SITE HAD RECENT CHANGES IN STAFF AND THE CUSTOMER SUSPECTED THIS MAY HAVE RESULTED IN THE INSUFFICIENT CLEANING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16642961 ↗
  • MalfunctionMar 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING MAINTENANCE, THE CLIP BROKE OFF AT THE TIPS WHEN DISCONNECTING THE CONNECTING TUBE AFTER REPROCESSING. SINCE THE CLIP BROKE OFF, THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BIN. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16585074 ↗
  • MalfunctionJan 31, 2023Material Integrity Problem; Material Integrity Problem

    THE CUSTOMER STATED THEY USED 3M ENZYME-DETERGENT 70508E, WHICH IS A NON-OLYMPUS PRODUCT, WITH THE REPORTED OLYMPUS DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16272165 ↗
  • MalfunctionApr 5, 2022Break; Break

    IT WAS REPORTED BY THE CUSTOMER, THE CONNECTING TUBE ON THE OER-PRO WAS FOUND BROKEN. SEVEN (7) SCOPES WERE REPROCESSED IN THE OER-PRO WITH THE BROKEN CONNECTING TUBE. THE SCOPES WERE THEN USED ON PATIENTS. ONE (1) SCOPE HAD BEEN USED ON TWO (2) DIFFERENT PATIENTS ON THE SAME DAY. PROCEDURE OR PATIENT IMPACT WAS UNKNOWN AS THE BROKEN PIECE OF TUBING WAS DISCOVERED AFTER PROCEDURES WERE PERFORMED. IT WAS UNKNOWN WHEN THE TUBING HAD BROKEN. PATIENT INJURY OR INFECTION WAS UNKNOWN. HOWEVER, TO DATE, NO PATIENT HARM HAD BEEN REPORTED. THE BROKEN CONNECTING TUBE WAS REPLACED, THE OER-PRO WAS FULLY OPERATIONAL, AND THE SCOPES WERE REWASHED. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6) (PCF-H190L), (B)(6) (GIF-H190), (B)(6) (CF-HQ190L), (B)(6) (CF-HQ190L), (B)(6) (GIF-H190), (B)(6) (GIF-H190),(B)(6) (CF-HQ190L), AND (B)(6) (GIF-H190).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14013640 ↗
  • 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/THE SUBJECT DEVICE, MAJ-1503, 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 ASSOC

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13301038 ↗
  • MalfunctionAug 16, 2021Break; Break

    THE CUSTOMER REPORTED, DURING A DIAGNOSTIC PROCEDURE, THE CLAMP END WAS BROKEN ON THE MAJ-1500 CONNECTING TUBE AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT/USER INJURY OR HARM REPORTED TO OLYMPUS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12328151 ↗
  • MalfunctionJul 16, 2021Device Reprocessing Problem; Device Reprocessing Problem

    DURING THE REPROCESSING, THE USER FOUND THAT THERE WAS A FOREIGN MATTER AT THE POINT OF INJECTION ON THE DEVICE WHICH CONNECTED TO THE OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR OER-5. THE USER THEN REMOVED THE SUBSTANCE. IT LOOKED LIKE A TRANSLUCENT ADHESIVE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12179292 ↗
  • MalfunctionMay 22, 2021Device Contamination with Chemical or Other Material; No Flow; Device Contamination with Chemical or Other Material; No Flow

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER FACILITY THAT DURING THE REPROCESSING OF THE UNSPECIFIED ENDOSCOPE WITH THE SUBJECT DEVICE (CONNECTING TUBE MAJ-1500), IT WAS FOUND THAT THE SUBJECT DEVICE WAS CLOGGED WITH FOREIGN MATERIAL SUCH AS SOMETHING LIKE A TRANSLUCENT ADHESIVE, AND THERE WAS NO FLUID FLOW THROUGH THE SUBJECT DEVICE, WHICH CONNECTED THE AUTOMATED ENDOSCOPE REPROCESSOR OER-5 (NOT AVAILABLE IN THE USA) TO THE ENDOSCOPE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11868406 ↗
  • MalfunctionApr 12, 2021Mechanical Problem; Mechanical Problem

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER FACILITY THAT AFTER THE REPROCESSING OF THE UNSPECIFIED ENDOSCOPE WITH THE SUBJECT DEVICE, IT WAS FOUND THAT THE CONNECTING TUBE WAS DISCONNECTED FROM THE CONNECTING TUBE CONNECTOR. THE USER FACILITY REPLACED THE SUBJECT DEVICE TO ANOTHER CONNECTING TUBE AND REPROCESSED THE ENDOSCOPE AGAIN, BECAUSE THERE WAS CONCERN ABOUT DETERGENCY. THIS ISSUE OCCURRED WITH THREE CONNECTING TUBES (MAJ-1500) INCLUDING THE SUBJECT DEVICE IN THIS REPORT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11654133 ↗
  • MalfunctionApr 12, 2021Mechanical Problem; Mechanical Problem

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER FACILITY THAT AFTER THE REPROCESSING OF THE UNSPECIFIED ENDOSCOPE WITH THE SUBJECT DEVICE, IT WAS FOUND THAT THE CONNECTING TUBE WAS DISCONNECTED FROM THE CONNECTING TUBE CONNECTOR. THE USER FACILITY REPLACED THE SUBJECT DEVICE TO ANOTHER CONNECTING TUBE AND REPROCESSED THE ENDOSCOPE AGAIN, BECAUSE THERE WAS CONCERN ABOUT DETERGENCY. THIS ISSUE OCCURRED WITH THREE CONNECTING TUBES (MAJ-1500) INCLUDING THE SUBJECT DEVICE IN THIS REPORT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11654065 ↗
  • MalfunctionApr 12, 2021Mechanical Problem; Mechanical Problem

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER FACILITY THAT AFTER THE REPROCESSING OF THE UNSPECIFIED ENDOSCOPE WITH THE SUBJECT DEVICE, IT WAS FOUND THAT THE CONNECTING TUBE WAS DISCONNECTED FROM THE CONNECTING TUBE CONNECTOR. THE USER FACILITY REPLACED THE SUBJECT DEVICE TO ANOTHER CONNECTING TUBE AND REPROCESSED THE ENDOSCOPE AGAIN, BECAUSE THERE WAS CONCERN ABOUT DETERGENCY. THIS ISSUE OCCURRED WITH THREE CONNECTING TUBES (MAJ-1500) INCLUDING THE SUBJECT DEVICE IN THIS REPORT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11654046 ↗
  • MalfunctionDec 11, 2020Mechanical Problem; Mechanical Problem

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER FACILITY THAT AFTER THE REPROCESSING OF THE UNSPECIFIED ENDOSCOPE WITH THE SUBJECT DEVICE, IT WAS FOUND THAT THE CONNECTING TUBE CONNECTOR WAS DISCONNECTED. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10989452 ↗

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