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

Model Number UHI-4

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Pressure Problem (3012)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the insufflator had an excessive pressure alarm sound and the actual pressure valve was giving a 3-4 reading above the set value.The issue occurred during a therapeutic laparoscopic hernia procedure.The procedure was completed with the same device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, since the subject device was not returned to olympus for evaluation, the reported defects (pressure exceeded the set value/alarm) were not confirmed.Therefore, the root cause could not be determined.This supplemental report includes additional information from the customer.A2, a4, and b5 have been updated with the additional information received.A correction has been made to d9 from the initial medwatch.Also, information has been added to d8 and h4.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that the set pressure was 14mmhg.The relief mode was set to ¿off,¿ the alarm delay setting was 1s, the flow rate setting was medium (12 l), and the indication for insufflation pressure was 20mmhg.The indication of insufflation pressure was not stable.No other gas source other than the subject device (uhi-4) was used.The facility does not use smoke evacuation mode; therefore, the pintchvalve was not exhausting smoke.Moreover, the overpressure warning alarm sounded, and the warning light was displayed.However, the tube obstruction warning alarm did not sound.Also, the smoke evacuation suction tube was not connected.The patient¿s abdomen was not distended, and there was no indication of increased intra-abdominal pressure observed.Although the device failure caused a 10¿15-minute procedural delay; there was no patient injury.

• 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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18952032
• MDR Text Key: 338887899
• Report Number: 3002808148-2024-02704
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/21/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/21/2024
• 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
• Treatment: MAJ-590 INSUFFLATION TUBE
• Patient Age: 42 YR
• Patient Weight: 79 KG