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UNKNOWN UNKNOWN Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
No device was returned to olympus for evaluation. The cause of the reported event cannot be determined at this time. If additional information is received at a later time, this report will be updated accordingly.
Event Description
Olympus was informed by the customer of an alleged patient infection following a cystoscopy procedure performed with an olympus cysto-nephro videoscope. The actual date of incident of the procedure is unknown. The type of infection is also unknown. The actual model of the scope used to examine the patient is unknown. The unidentified cystoscope was said to have been reprocessed in a non-olympus automated endoscope reprocessor (steris). No further information was provided.
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Type of DeviceUNKNOWN
Manufacturer (Section D)
MDR Report Key7308581
MDR Text Key101372690
Report Number2951238-2018-00144
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/01/2018 Patient Sequence Number: 1