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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396 URETEROSCOPES, AUTOCLAVABLE

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OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396 URETEROSCOPES, AUTOCLAVABLE Back to Search Results
Model Number WA29042B
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
There was no device returned to olympus for evaluation/investigation. Therefore, the exact cause of the patients' outcomes and the reported phenomenon could not be determined and is being judged as unknown. The case will be closed from olympus side with no further actions but may be reopened if a device is returned for evaluation/investigation or additional significant information becomes available at a later time. Then, this report will be updated. Furthermore, the reported events/incidents will be recorded for trending and surveillance purposes. Please note: this report is being submitted although the suspect medical device is not marketed in the usa. However, a similar device is marketed. Model # / catalog #: wa29042a; brand name: ureteroscope, 8,6/9,8 fr. X 430 mm, 7°, 6,4 fr. Channel, with wa00396a; common device name: ureteroscopes, autoclavable; 510(k): k951855; product code: fgb.
 
Event Description
Olympus was informed that after unspecified endoscopic procedures at unknown dates, seven patients developed a urinary tract infection. No further information was provided and the cause of this complication is unknown as well.
 
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Brand NameURETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396
Type of DeviceURETEROSCOPES, AUTOCLAVABLE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM 22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM 22045
Manufacturer Contact
daniel wladow
kuehnstrasse 61
hamburg 22045
GM   22045
4940669662
MDR Report Key6180308
MDR Text Key62545293
Report Number9610773-2016-10008
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PK951855
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWA29042B
Device Catalogue NumberWA29042B
Other Device ID Number04042761068376
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2016
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 Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
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