CIRCON ACMI * GDAC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-18 for CIRCON ACMI * GDAC manufactured by Circon Acmi.

Event Text Entries

[180659] Dr felt as if active cord did not properly hook onto resectoscope. Dr was shocked several times while attempting to adjust active cord.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 275025
• MDR Report Key: 275025
• Date Received: 2000-04-18
• Date of Report: 2000-03-10
• Date of Event: 2000-03-10
• Date Facility Aware: 2000-03-10
• Report Date: 2000-03-10
• Date Reported to Mfgr: 2000-03-14
• Date Added to Maude: 2000-04-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CIRCON ACMI
• Generic Name: DISPOSABLE ACTIVE CORD
• Product Code: FFZ
• Date Received: 2000-04-18
• Model Number: *
• Catalog Number: GDAC
• Lot Number: FC13803
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 266200
• Manufacturer: CIRCON ACMI
• Manufacturer Address: 300 STILLWATER AVE. STAMFORD CT 069033695 US
• Baseline Brand Name: USA ELITE SYSTEM/USA SERIES DISPOSABLE ACTIVE CORD
• Baseline Generic Name: 500
• Baseline Model No: GDAC
• Baseline Catalog No: GDAC
• Baseline Device Family: R2500
• Baseline Shelf Life Contained: N
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-04-18