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

Model Number UHI-3

Device Problem No Flow (2991)

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

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc for evaluation but was returned to olympus (b)(4).Olympus (b)(4) checked the subject device and found that the reported phenomenon (insufflation failure) was not duplicated, however the insufflation was stopped due to the failure of the internal decompressor.In addition, it was also found that the subject device had been repaired by the third party.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomena (the insufflation failure and the internal decompressor failure) could not be conclusively determined.However, based upon the information from olympus (b)(4), omsc surmised that the reported insufflation failure was attributed to the failure of the main circuit board because the subject device had been repaired by the third party.And it was surmised that the reported internal decompressor failure was attributed to the something due to the repair by the third party, or the aging deterioration because ten years and nine months had passed since manufacturing.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that during the preparation for a laparoscopic surgery using the subject device in combination with the video processor otv-s7, it was found that the insufflation of the subject device was not possible.The user facility 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
• MDR Report Key: 12426320
• MDR Text Key: 280897648
• Report Number: 8010047-2021-11269
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 09/05/2021

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: No Information
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1