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

Model Number MAJ-1082

Device Problem Material Rupture (1546)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the carbon dioxide cylinder hose external sheath ruptured.The issue was found during preparation for use.It was also reported that the insufflator was off and the carbon dioxide was not in use.There were no reports of patient harm.

Manufacturer Narrative

The device was not returned to olympus for evaluation but has not yet been evaluated.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The outer sheath of the high pressure hose is torn.There are no scratches or tears on the inner hose, and there is no co2 leakage.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, it is likely that the external capsule was damaged from wear and tear and usage over time.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: 17455584
• MDR Text Key: 320422601
• Report Number: 3002808148-2023-07944
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04953170140334
• UDI-Public: 04953170140334
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K063786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

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-1082
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 09/26/2023
• 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