MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. BALLOON

Model Number MAJ-213

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/30/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was not sent to olympus for evaluation.A review of the instruction manual found it states "must be sterilized" but the product package label states "sterilize as necessary".The device history record was unable to be reviewed for this device since the serial 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 legal manufacturer's investigation, it was discovered that the label on the package stating "sterilize as needed" was incorrect and the product must be sterilized according to the instructions.A definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported that, when the facility checked the package insert, the package insert for the subject device states that sterilization is required, but the product package label states sterilize as needed.This was the first time the discrepancy was noted, and the facility had previously used the product without sterilization.There have been no reports of infection and doctors have not seen it as a problem, but the customer has complained that there may be a problem with the way olympus writes it.

• Brand Name: BALLOON
• Type of Device: BALLOON
• 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: 16294087
• MDR Text Key: 308867389
• Report Number: 3002808148-2023-01052
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170355714
• UDI-Public: 04953170355714
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2023

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-213
• Device Catalogue Number: N5361430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1