MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. INJECTION TUBE

Model Number MH-946

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc for evaluation.The reprocessing trainer has a rough assumption that almost 50% of the (b)(6) customer does not use the mh-946 since there is no clear instruction how to reprocess the mh-946 with wd.As an actual situation in the market, the manual reprocessing process is only applicable for emergency cases in the hospital.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

A trainer of the (b)(6) nurse association informed an olympus representative that a nurse told the trainer that the nurse had experienced heavy contamination of the device.The conversation occurred during reprocessing training provided by the trainer.No detailed information is available regarding the exact customer name, number of contaminated mh-946s or contamination results.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus contacted the trainer of the german nurse association but was unable to obtain additional information.The device was not returned to olympus medical systems corp.(omsc), therefore omsc could not investigate the device.The exact cause of the reported event could not be conclusively determined.If significant additional information is received, this report will be supplemented.

• Brand Name: INJECTION TUBE
• Type of Device: INJECTION TUBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10834210
• MDR Text Key: 225202369
• Report Number: 8010047-2020-08881
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170286421
• UDI-Public: 04953170286421
• Combination Product (y/n): N
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MH-946
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1