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

Model Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

The customer reported to olympus an unidentified duodenovideoscope was used in an outpatient during an endoscopic retrograde cholangiopancreatography (ercp).And the patient subsequently may have developed an infection.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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, a relationship between the subject device and the reported infection could not be identified.Therefore, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ olympus will continue to monitor field performance for this device.

• Brand Name: UNKNOWN
• Type of Device: DUODENOVIDEOSCOPE
• 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: 17446181
• MDR Text Key: 320289911
• Report Number: 9610595-2023-11051
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model 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: 09/14/2023
• 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
• Patient Outcome(s): Other