MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYLINDER HOSE

Model Number MAJ-1080

Device Problem Connection Problem (2900)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc.Omsc checked the subject device and found that there was no abnormality on the exterior of the subject device.Also omsc found that the subject device could be connected to the uhi-4 which was asset of omsc correctly and the subject device could function without problem.The investigation is in progress currently.The exact cause of the reported event could not be conclusively determined at this time.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the installation of the uhi-4 which was returned to the facility after the repair, the cylinder hose (maj-1080) could not be connected to the uhi-4.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc could not reviewed the manufacture history (dhr) of the subject device because the serial number of the subject device was unknown.The cause of the indicated phenomenon is the deformation of the co2 gas inlet of the uhi-4.Since there is no abnormality in this product, it is considered that the failure of only uhi-4.The cause of the uhi-4 failure could not be identified, but it is considered that it was caused by external force being applied.If additional information becomes available, this report will be supplemented.

• Brand Name: CYLINDER HOSE
• Type of Device: CYLINDER HOSE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12426408
• MDR Text Key: 273216125
• Report Number: 8010047-2021-11281
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

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: Other
• Device Model Number: MAJ-1080
• Device Lot Number: 7637702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/05/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 10/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1