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

Model Number UHI-4

Device Problem Increase in Pressure (1491)

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

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that at the beginning of the elective, total extraperitoneal inguinal repair (tep) left sided inguinal hernia repair, the high flow insufflation unit alarmed for overpressure warning with the light on and pressure indicator fluctuating between 6 and 18 mm hg.The overpressure occurred immediately after port placement and insufflation was attempted.Reportedly, there was no gas source other than uhi4 used.The procedure began with setting up of the laparoscopy ports in the abdominal wall to create a working space behind the rectus abdominis muscle.At the beginning of the procedure, the insufflation unit (set at pressure of 10-12mmg hg, device flow setting was high at 45l/min, unknown if evacuation hose was connected) the pressure began to alternate intermittently with alarm and no smoke.It was unknown if the hose was connected.Troubleshooting was attempted changing hose and filters and procedure was resumed, however the same issue recurred.As the medical staff could not find any source that caused high pressure, the procedure was cancelled (consultation of the anesthesiologist) due to continuous insufflation that elevated the carbon dioxide levels by approximately 1 unit and pressure rose to 6.8 mmhg.Reportedly the patient¿s abdominal cavity was not distended at all due to the device, malfunction.The retro rectus was insufflated at the beginning of the procedure and no increase in the intra-abdominal pressure.The patient's condition was reported as excellent.

• 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: 19176120
• MDR Text Key: 340977318
• Report Number: 3002808148-2024-03838
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2012
• 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