MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problems Increase in Pressure (1491); Free or Unrestricted Flow (2945); Fail-Safe Did Not Operate (4046)

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

Event Type  malfunction  

Event Description

The customer reported that after an unspecified therapeutic procedure was successfully completed, they noticed the patient¿s intra-abdominal pressure was high.This was noted after multiple procedures.No specific dates were known.The customer suspected that the subject device may have increased the intra-abdominal pressure.A da vinci surgical system was also in-use during the intended procedures.The subject device was inspected prior to the intended procedures and no anomalies were observed.There was no patient or user injury reported due to the event.A second event with the subject device is being reported on the medwatch with patient identifier (b)(4).

Manufacturer Narrative

The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported issue (increased pressure) was not confirmed or duplicated.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to g2.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the high intra-abdominal pressure was unable to be identified.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to correct the h6 problem code and to provide additional information in h7/h9.A formal investigation was initiated to investigate the root cause.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15130882
• MDR Text Key: 304553690
• Report Number: 3002808148-2022-00478
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• 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: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• 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: 07/10/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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: DA VINCI SURGICAL SYSTEM.