MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYLINDER HOSE

Model Number MAJ-1080

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A biomedical engineer reported to olympus, the cylinder hose o-rings (washers) were missing.There is a high pressure hose connection failure due to damaged or o-ring lock nut falling off.There was no report of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to b5.Please see updates to b5, h6 and h10.B5: the information included in b5 was inadvertently omitted from the initial medwatch.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned for evaluation.Based on the results of the investigation, the root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported the issue they were having was due to their staff wanting to add additional washers when replacing the tanks.The customer noted that in the past they had a different yoke that slides from the top and it secures by using a small gray washer that came with the new tank.After doing some testing they were able to use the yoke without additional washers, but their staff is still convinced that it needs to have an additional washer.

• Brand Name: CYLINDER HOSE
• Type of Device: CYLINDER HOSE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15949622
• MDR Text Key: 308242656
• Report Number: 3002808148-2022-05053
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140310
• UDI-Public: 04953170140310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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