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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN UNKNOWN

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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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Brand NameUNKNOWN
Type of DeviceUNKNOWN
Manufacturer (Section D)
UNKNOWN
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
408935-512
MDR Report Key7308581
MDR Text Key101372690
Report Number2951238-2018-00144
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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 HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/16/2018
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 Unkown

Patient TREATMENT DATA
Date Received: 03/01/2018 Patient Sequence Number: 1
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