MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)

Model Number MAJ-1985

Device Problem Component Missing (2306)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and the device evaluation confirmed the customer¿s allegation.The device evaluation determined the o-rings on connectors a and b were missing.The device appeared to be in a new condition as all of the screws were still in sealed bags.The review of the device history record (dhr) did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The legal manufacturer performed an investigation and was unable to determine the exact root cause of the missing o-rings (gasket).The investigation determined since the subject device was ancillary equipment, the o-rings most likely went missing after the device had been purchased.The probable cause of the missing o-rings were either it was not properly tightened when replaced or it had deteriorated with use.Follow up with the user facility is currently being performed.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The customer¿s olympus sales representative reported to olympus, there was an out of box failure with the cylinder hose with switch-over valve (pin-index).The o-ring (gasket) was missing on the cylinder hose.There were no reports of patient harm associated with this event.

Manufacturer Narrative

Corrected data: initial aware date was reported as 8/19/2021 when it was 8/20/2021 in g3.

Event Description

Additional information regarding this event was obtained from the user facility.The subject device failed during a laparoscopic cholecystectomy when the co2 was deleted and the tank needed to be switched out.The procedure was able to be completed with the subject device.The design of the device allows the use of another hose.The user facility switched to hose b to finish out the procedure and manually switch out the tank.There was a five minute delay in the procedure.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The aware date should be 13-jul-2021.Olympus will continue to monitor the field performance of this device.

• Brand Name: CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)
• Type of Device: CYLINDER HOSE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12485629
• MDR Text Key: 276360721
• Report Number: 8010047-2021-11854
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324208
• UDI-Public: 04953170324208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2022

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
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/20/2021; 10/02/2022
• Supplement Dates FDA Received: 10/19/2021; 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1