MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. UNKNOWN; GASTROINTESTINAL VIDEOSCOPE

Model Number UNKNOWN

Device Problem Device Reprocessing Problem (1091)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

The third-party wishes to remain anonymous.Since the device is unknown, for the purpose of mdr processing, the following fields are populated with placeholder values as actual values are not known: device manufacturer and manufacturing site details, fda product code, fda 510(k) / exempt / pma, common device name (usa).A definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Event Description

It was reported to the olympus employee by a third-party that the facility was not reprocessing in the correct manner.There is no further information provided.Due diligence is being performed to gather more information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 investigation, the root cause of the third party report of the facility not properly performing the device reprocessing could not be determined, as no additional event or reprocessing information was reported or available.Olympus will continue to monitor field performance for this device.

• Brand Name: UNKNOWN
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16683902
• MDR Text Key: 313237483
• Report Number: 9610595-2023-05633
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2023
• 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