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

Model Number MAJ-1500

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The user¿s complaint was not confirmed.No findings available.The cause could not be determined.The user called to get pricing to replace the device.No further information was reported.A supplemental will be submitted if new information becomes available or the device is returned.

Event Description

The user facility reported that there was an issue with the maj-1500 device.The connecting tube has broken tabs.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

The device is not returned.As such, an actual device evaluation is not performed.An evaluation is done based on historical records and communication.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h3, h6, and h10.The device history record review was not possible as the lot number of the device is unknown.The manufacturing date is also not available as the lot number of the device is not known.The customer reported that the device connecting tube had broken tabs.The device is not available for evaluation.The customer ordered the part and replaced it themselves.Customer did not have any additional information for the event, other than the reported information.The cause of the event cannot be conclusively determined.The issue could have taken place at the time the scopes were reprocessed and the connecting tube connecter was about to be broken, which led to disconnection due to fluid/air pressure at reprocessing.The breakage of the connecting tube may have occurred by impact added to the connector and/or deterioration by age.

• 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: 10379163
• MDR Text Key: 202037310
• Report Number: 8010047-2020-05381
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1