MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD CYLINDER HOSE

Model Number MAJ-1080

Device Problems Leak/Splash (1354); Component Missing (2306)

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

Event Date 07/25/2022

Event Type  malfunction  

Event Description

Customer reported leaking on the device and stated machine was inspected and realized the o-ring was missing.The issue found during an unknown event.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

The subject device was not returned for evaluation.The lot number was not provided and is unknown.Technical assistance center (tac) support engineer communication with the customer noted that tac provided the part number for o-ring and customer will obtain a replacement.No troubleshooting performed as customer will purchase a replacement instead.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to e2, g2, h6 and h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it¿s likely the gas leak was due to the o-ring being disconnected from the hose.The root cause of the disconnected o-ring was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: CYLINDER HOSE
• 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: 15272354
• MDR Text Key: 305009194
• Report Number: 3002808148-2022-01270
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140310
• UDI-Public: 04953170140310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014166
• 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
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2022
• 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