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Adverse Event Report

CIRCON ACMI CIRCON ACMI RESECTOSCOPE-27 FRENCH   back to search results
Event Date 08/17/1994
Patient Outcome  Required Intervention;
Event Description

Pt with invasive bladder cancer admitted with gross hematuria requiring continuous bladder irrigations. Underwent turbt and fulguration, perineal urethrostomy and evacuation of bladder clots. On removal of resectoscope, the distal end and insulating portion broke off and was seen in the bladder. This piece was removed with a catheter. No active bleeding was noted on final inspection. The pt remains in the hosp for his underlying condition (continued hematuria).

 
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Brand NameCIRCON ACMI
Type of DeviceRESECTOSCOPE-27 FRENCH
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
CIRCON ACMI
309 half moon bay drive
croton on hudson NY 10520
Device Event Key47082
MDR Report Key46236
Event Key43338
Report Number46236
Device Sequence Number1
Product CodeFJL
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 08/25/1994
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/1996
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/22/1994
Device Age7 mo
Event Location Hospital
Date Report TO Manufacturer08/25/1994
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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