MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number MAJ-1500

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the subject device and confirmed that the junction between the equipment side connector and the tube of the subject device was broken.Since the lot number is not identified the manufacturing history record (dhr) could not be reviewed.However, omsc has only shipped devices which passed the inspection.The exact cause of the reported event could not be determined, but it is surmised that the subject device was broken due to fatigue breakage by repeated use.The instruction manual of the device has already warned as follows; over time, the connecting tube will deteriorate because it is subject to wear with each use.If any of the following are found with the connecting tube, do not use it and replace it with a new one.Connecting a defective tube could prevent the effectiveness of the cleaning and high-level disinfection process.

Event Description

Olympus medical systems corp.(omsc) was informed that the junction between the equipment side connector and the tube of the subject device was broken.Other detailed information such as when the breakage of the subject device occurred was not provided from the user facility.There was no report of patient injury associated with the event.

• Brand Name: CONNECTING TUBE
• Type of Device: ENDOSCOPE REPROCESSOR ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9876496
• MDR Text Key: 221300743
• Report Number: 8010047-2020-01858
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170233937
• UDI-Public: 04953170233937
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1