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

Model Number UHI-4

Device Problems Electrical /Electronic Property Problem (1198); Failure to Power Up (1476); Insufficient Flow or Under Infusion (2182)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus (b)(4).Olympus (b)(4) checked the subject device and found that the reported phenomenon (power up failure) was not duplicated, and also found the following.The indicators on the front panel became blackout occasionally, due to failure of the printed circuit board.The amount of insufflation did not reach the maximum value, due to the failure of the component.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported power up failure could not be conclusively determined.However, based upon the information from olympus china and similar past cases, omsc surmised that this power up failure was attributed to the failure of the power supply board or the main circuit board.In addition, based upon the information from olympus china and similar past cases, omsc concluded that the front panel failure was attributed to the failure of the main circuit board, which might be caused by the accidental failure of the electrical component.Also, omsc concluded that the insufflation failure was attributed to the failure of the primary pressure reducing valve, which might be caused by the accidental failure of the primary pressure reducing valve.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during preparation for the therapeutic laparoscopy using the subject device in combination with the video processor otv-s190 and the light source clv-s190 (patient was not under anesthesia), it was found that the front panel of the subject device had failure and the power of the subject device could not be turned on.The user replaced the subject device to another similar device to complete the procedure without more than fifteen minutes extension.There was no report of patient injury associated with this event.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12662369
• MDR Text Key: 277398099
• Report Number: 8010047-2021-13395
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1