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

Model Number UHI-3

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2018

Event Type  malfunction  

Manufacturer Narrative

The subject uhi-3 was not returned to olympus medical systems corp.(omsc).Omsc will investigate the subject uhi-3 to identify the root cause of this failure phenomenon when omsc receives it.The uhi-3 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

(b)(6) informed olympus (b)(4) of the event below on march 13th, 2019: on (b)(6) 2018, during laparoscopic cholecystectomy, insufflation was not effective, resulting in insufficient abdominal space.Abdominal pressure indicator on the subject uhi-3 was displayed as the set value.But actually, the abdomen was soft and could not be operated on.No abnormalities were found in the insufflation tubes.The user adjusted the intra-abdominal pressure setting of the machine, the effect was still not good.The user replaced the subject uhi-3 with an unspecified pneumoperitoneum device and the procedure was completed.There was no report of the patient¿s injury regarding 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: 8476854
• MDR Text Key: 140787064
• Report Number: 8010047-2019-01511
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 28 YR