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

Model Number UHI-4

Device Problems Loose or Intermittent Connection (1371); Pressure Problem (3012)

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

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device inspection and evaluation, service repair noted the following findings: visual inspection performed and no abnormality found in the appearance.Device actual testing/confirmation noted that the problem was not reproduced , noted operation confirmation not possible due to the power does not turned on.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported during a gynecological tlh surgery (therapeutic laparoscopic hysterectomy), when the surgeon was pneumoperitoneum with middle flow, the abdominal pressure did not rise sufficiently compared to normal.The surgeon then switched to high flow , no abnormality found in the uhi-4 device display, the abdominal pressure increased and the intended procedure was completed without any problems.There was no patient harm or injury reported due to the event.No user injury reported.After the operation, the facility staff inspected the equipment and found that the nut at the connection with the gas cylinder of the maj-1985 (cylinder hose with switch-over valve (pin index) was loose.The facility staff tightened the nut.This event includes two (2) reports: report with patient identifier (b)(6) (uhi-4: sn: (b)(4)) high flow insufflation unit.Report with patient identifier (b)(6) maj-1985 - cylinder hose with switch-over valve (pin index).This report is for patient identifier (b)(6) (uhi-4: sn: (b)(4)) high flow insufflation unit.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been nearly 9 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the cause of the phenomenon ¿nut was loose at the gas cylinder of maj-1985¿ was attributed to the nut not tightened enough at the o-ring.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿replacement procedure for packing (o-ring): 7.Using the wrench (6mm), tighten the o-ring lock nut (with a force of about 2 n-m (reference), for example).¿ olympus will continue to monitor field performance for this device.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD; 3-1 okamiyama- 1; 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: 15058153
• MDR Text Key: 304799768
• Report Number: 3002808148-2022-00092
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• 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: 06/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2013
• 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-1985