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Adverse Event Report

CIRCON ACMI USA SERIES FLEXIBLE URETEROPYELOSCOPE URETEROSCOPE   back to search results
Model Number AUR-7
Event Date 04/07/2000
Event Type  Malfunction  
Event Description

During procedure physician noticed tears on the on the pt's kidney. The physician withdrew the scope and reportedly noticed a tear or gash on the distal end of the sheath. A nurse present at the time reported that the gash on the shaft was approximately 3" long. The physician elected to remove the kidney after physician discovered the tears.

 
Manufacturer Narrative

The hosp is retaining the subject device for its own investigation. It is not known if or when the device will be retunred to the mfr for eval.

 
Manufacturer Narrative

Subject device examined with the unaided eye and at 6x optical magnification. The shaft cover of the device was torn and separated, exposing braid from 60cm to 90 cm from the distal end. The problem likely was caused by customer damage.

 
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Brand NameUSA SERIES FLEXIBLE URETEROPYELOSCOPE
Type of DeviceURETEROSCOPE
Baseline Brand NameUSA SERIES AUR-7 FLEXIBLE URETEROPYELOSCOPE
Baseline Generic NameURETEROSCOPE
Baseline Catalogue NumberAUR-7
Baseline Model NumberAUR-7
Baseline Device FamilyURETEROSCOPE
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Manufacturer (Section F)
CIRCON ACMI
300 stillwater street
stamford CT 06904
Manufacturer (Section D)
CIRCON ACMI
300 stillwater street
stamford CT 06904
Manufacturer Contact
mary pickard
6500 hollister ave
santa barbara , CA 93117
(203) 328 -8721
Device Event Key266137
MDR Report Key274956
Event Key257790
Report Number1218764-2000-00002
Device Sequence Number1
Product CodeFGB
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation RISK MANAGER
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/18/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberAUR-7
Device Catalogue NumberAUR-7
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/26/2000
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/26/2000
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on December 31, 2008

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