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

Model Number UHI-4

Device Problem Inaccurate Delivery (2339)

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

Event Date 09/08/2021

Event Type  malfunction  

Event Description

It was reported by the customer, there was an intermittent issue with the high flow insufflation unit.The unit could not achieve the requested pressure quickly.The flow was set to ten (10) and the unit did eight (8).Requested pressure of fifteen (15) and the device fluctuated between eight (8) and eleven (11) over a couple of minutes (eleven (11) brief max).The issue had occurred multiple times.The unit was unable to keep pressure when using smoke evacuation.The biomedical engineer could not replicate the issue during testing.The biomedical engineer witnessed users having an issue a week later with no smoke evacuation involved.The unit was fine when restarted for testing.The issue occurred during a procedure.No reported patient harm.This complaint is related to patient identifier: (b)(6).

Manufacturer Narrative

The subject device has been received and is currently in the evaluation process.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

Additional information was received from the customer.The device had failed in the beginning of a therapeutic laparoscopic cholecystectomy with lysis of adhesions.There was no patient harm, only a loss of visualization and increased surgical time of fifteen (15) ¿ twenty (20) minutes.The intended procedure was completed with another high flow insufflation unit.No other devices were involved in the event and no other device were replaced.The device had been inspected two (2) weeks prior after a similar incident where the device was unable to maintain pressure, but the user turned off the smoke evacuation to continue the case.The biomedical engineer was unable to replicate any problems with the device during testing.Only the same device ever caused issues.The facility had been using an older device on the same tower since without any issues.It was believed there was at least one more event that was never documented but the facility managed to finish the procedure and then did not have any issues on the following procedures until the next event.This complaint is related to patient identifiers (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer and the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.The issue may have been caused by the following factors: an influence other than the device (connected device, connection status, patient status).Failure of various sensors inside the device.

• 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: 12569802
• MDR Text Key: 280936978
• Report Number: 8010047-2021-12661
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TOWER, MODEL # UNKNOWN