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

Model Number UHI-4

Device Problem Device Sensing Problem (2917)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The manufacturing record was reviewed and found no irregularities.Omsc checked the subject device and found that the reported phenomenon could not be duplicated.Omsc checked the error log and found that e03 (pressure sensor abnormality) had occurred.Therefore, omsc presumed that the reported phenomenon occurred due to the abnormality in the pressure sensor.

Event Description

Olympus medical systems corp.(omsc) was informed that at the end of the laparoscopic inguinal hernia repair, the abdominal pressure dropped to 2 mmhg and there was almost no flow rate.After that, an alarm sounded and the supply stopped.The procedure was completed without replacing the equipment.There was no report of patient injury associated with the 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: 12187249
• MDR Text Key: 262516155
• Report Number: 8010047-2021-09038
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• 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: 07/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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