MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)

Model Number MAJ-1985

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available and or received.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) ((b)(4) ) cylinder hose with switch-over valve (pin index) this report is for patient identifier (b)(6) ((b)(4)cylinder hose with switch-over valve (pin index).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation and device evaluation.Sections d4, d9, h3, h4, h6, and h10 were updated.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.There was no abnormality in the appearance.There is no abnormality when connecting and operating according to the instruction manual.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 definitive root cause of the pressure issue was a loose nut that was fixed to the o-ring.It may not have been tightened enough.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿ 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: CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)
• Type of Device: CYLINDER HOSE
• 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: 15058522
• MDR Text Key: 301649909
• Report Number: 3002808148-2022-00093
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324208
• UDI-Public: 04953170324208
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110294
• 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: 09/22/2022

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: MAJ-1985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2013
• 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: UHI-4: SN: (B)(6) HIGH FLOW INSUFFLATION UNIT