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 08/14/2019

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

During reprocessing for an unspecified endoscope with oer-4 and maj-1500, the user found the tube of maj-1500 was broken.Fluid was jetting from the broken part of the tube.The user reported that they did not know when the tube broke or how long the subject device was used.After replacing the subject maj-1500 with another maj-1500, the endoscope was successfully reprocessed.There was no patient injury report related to the event.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2019-03295.Olympus medical systems corp.(omsc) could not investigate the subject maj-1500, because the subject maj-1500 was not returned to omsc.Since the subject device was not returned, the exact cause was not determined; however, the following are potential cause.Based on the similar case, the tube likely broke due to degradation during long years use.The instruction manual of maj-1500 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: visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities.

• 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: 9074646
• MDR Text Key: 219188775
• Report Number: 8010047-2019-03295
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1