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

Model Number MAJ-1080

Device Problem Pressure Problem (3012)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.Evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was returned and the evaluation found no malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed during the device inspection, that the high pressure the hose rubber seal was damaged.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.It is also being supplemented to add information to sections e1, e3, and g2.Company representative was inadvertently marked in g2 in the initial mdr.The manufacturing date cannot be identified in section h4 because the serial/lot number is unknown.This information was not provided in the previous report.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.Based on the results of the investigation, olympus presumed that the event was caused by a damaged rubber packing, however, the root cause could not be identified.Olympus will continue to monitor field performance for this device.

• 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: 19159881
• MDR Text Key: 341286933
• Report Number: 3002808148-2024-03740
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140310
• UDI-Public: 04953170140310
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/22/2024; 05/10/2024
• Supplement Dates FDA Received: 04/22/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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