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

Model Number MAJ-1500

Device Problem Mechanical Problem (1384)

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

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

The subject maj-1500 has not been returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed that one of two lock levers at the equipment side connector of maj-1500 was broken.The users performed unspecified procedure on a (b)(6) patient using an endoscope.The user reprocessed the endoscope with the broken maj-1500 and oer-4 and then used the endoscope for another patient.The user is scheduling a blood test for the 2nd patient three months later.An olympus service engineer reported that there is a possibility that reprocessing for the endoscope was insufficient due to the broken maj-1500.There was no report other than above.

Manufacturer Narrative

This is a supplemental report.The subject maj-1500 was returned to olympus medical systems corp.(omsc) for evaluation.One of two lock levers at the equipment side connector of maj-1500 was broken.Based on the similar case, the lock lever likely broke due to degradation and repeated loading during long time use.The instruction manual provides of maj-15000 provides warnings and how to inspect the device prior to use as follows.There were no further details provided.If significant additional information is received, this report will be supplemented.Warning 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.Inspection move the lock levers of the connecting tube to make sure that they function properly and are not broken.

• 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
• MDR Report Key: 8815029
• MDR Text Key: 208316721
• Report Number: 8010047-2019-02632
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170233937
• UDI-Public: 04953170233937
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• 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: -
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1