MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problems Break (1069); Defective Component (2292); Ambient Noise Problem (2877)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation found the unit was found to have a no insufflation malfunction due to a damaged gas tube, co2 pipe connector and electropneumatic proportional valve unit.Additionally, there is a damaged front panel, front chassis deformation, bottom chassis deformation., no top cover nut, two foot and two screws on the foot, two connectors on the main board are damaged, the connector of the manifold unit is damaged.Abnormal noise due to damage to the four dampers that support the manifold unit and the lack of four screws to stop the primary decompressor.There is a loud noise when supplying air due to damage to the gas tube.The repair is pending.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed that a customer high flow insufflation unit was returned due to a report of "there are problems, there is a loose part inside and is very loud on insufflation" observed during reprocessing.Upon inspection and testing, the unit was found to have a no insufflation malfunction due to a damaged gas tube, air pipe and electropneumatic proportional valve unit.No patient injury or harm was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: g3, g6, h2, h4, h6 and h10.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause of the reported malfunction could not be conclusively determined, however, the product was potentially damaged due to external force applied because the appearance was damaged or deformed and the internal parts were also removed and deformed.The legal manufacturer will continue to monitor the field performance of this device.

Manufacturer Narrative

The oem performed the device history records for the concerned device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A review of the repair records indicated the referenced device had no repair history in the past year.The investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The concerned device was not returned to the oem for evaluation, therefore the exact cause of the report malfunctions could not be conclusively determined.The abnormal sound is heard (inability to air) is due to the inner tubing was damaged which was potentially caused by external force applied because the appearance was damaged or deformed and the internal parts were also removed and deformed.Additionally, the reported insufflation is not possible is due to the inner tubing, k-connector, and electro-pneumatic proportional valve were damaged which were potentially caused by external force applied because the appearance was damaged or deformed and the internal parts were also removed and deformed.The oem will continue to monitor complaints for this device.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12086872
• MDR Text Key: 271331365
• Report Number: 8010047-2021-08138
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2021

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: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 07/15/2021; 08/30/2021
• Supplement Dates FDA Received: 07/23/2021; 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1