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

Model Number UHI-4

Device Problems Gas Output Problem (1266); Free or Unrestricted Flow (2945); Fail-Safe Did Not Operate (4046)

Patient Problems Abdominal Distention (2601); No Code Available (3191)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation, therefore omsc could not investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the information from (b)(4), there was possibility that this phenomenon was attributed to the effects of device connected to the subject device, such as a suction device, or effects of other than device such as patient's condition or the condition of the devices connection.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that at the beginning of a laparoscopic colectomy with the subject device, the set pressure of the subject device was 14 mmhg but the cavity pressure was increased to 30-40 mmhg and air flow feeding did not stop with no excessive pressure alarm.The user facility abandoned the procedure and released abdominal pressure immediately, then changed the laparoscopic colectomy to an open surgery.After the procedure, the patient was to be treated for colon cancer with radiation.There was no further report of patient injury associated with this event except the reported issue.The service engineer of olympus (b)(4) checked the subject device and found that the reported phenomenon was not duplicated and the subject device functioned correctly, also the subject device passed all inspections.

Manufacturer Narrative

This report is being supplemented to correct the h6 codes and h7.A formal investigation was initiated to investigate the root cause.

Manufacturer Narrative

This report is being supplemented to provide correction to the initial with information inadvertently left out.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.The complete evaluation results are as followed: all the topic and running test: the result is pass.The event can be prevented by following the instructions for use which state: "upon the occurrence of an abnormality in chapter 7" "7.1 identification of the cause of the abnormality and how to deal with it." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to provide additional information obtained from the customer (see b5).

Event Description

The customer provided additional information regarding event: the patient was 40-50 years old and had a body size of 60-70 kg.The overpressure occurred during a laparoscopic cholecystectomy.The patient's abdominal cavity was abnormally distended, and the device pressure displayed around 30-40 mmhg.There was no decrease in anesthesia levels.When asked whether the air was pumped into a small space inside the body, the customer responded not possible.The customer also confirmed they did not close the trocar cock or perform any other operation that would block the airway just before the pressure reached 30 mmhg.They could not confirm the reason for determining "non-stop feeding flowrate".The equipment has been used after inspection and no similar problems have occurred.The customer also confirmed the device settings at the time of the event: pressure set to 14 mmhg, relief mode (on or off) set to off, alarm delay (0s or 4.5s) set to 0s; flow rate (high /normal / low) set to normal.The device was indicated for insufflation pressure around 30-40 mmhg and the customer was unable to confirm if the pressure was stable.No gas source other than the uhi-4 was used, only used from the co2 tank.The pintchvalve was not exhausting smoke; the overpressure warning beeped; the overpressure warning light occurred; the tube clogging warning beeped.The smoke evacuation suction tube was not connected.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer's contact information and facility registration number.The facility registration number is 3002808148.

• 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: 10814942
• MDR Text Key: 215516327
• Report Number: 8010047-2020-08728
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0075-2024
• Patient Sequence Number: 1
• Treatment: ENDOPATH XCEL 12 MM BLADELESS TROCAR; WA95007A TUBING
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male