STORZ IMAGING SYSTEM C-ARM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-26 for STORZ IMAGING SYSTEM C-ARM * manufactured by Fisher Imaging Corp..

Event Text Entries

[20136704] The x-ray imaging system was used during a cystoscopic procedure. While the dr was positioning the dual monitor c-arm, the mounting assembly broke off. Dr was able to catch monitors when they fell. Pt was not injured whatsoever. Monitors were set aside and procedure was completed with no problem. Inspection of the monitor c-arm found that the two bolts holding the arm broke off and were level with the column. The remnants of the bolts were removed from the column with a punch. All pieces of the bolts were sent to mfr for evaluation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	2020550-1997-00006
MDR Report Key	72540
Date Received	1997-02-26
Date of Report	1997-02-24
Date of Event	1997-01-29
Date Facility Aware	1997-01-29
Report Date	1997-02-25
Date Reported to FDA	1997-02-25
Date Reported to Mfgr	1997-02-25
Date Added to Maude	1997-03-05
Event Key	0
Report Source Code	Distributor report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
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	STORZ IMAGING SYSTEM C-ARM
Generic Name	C-ARM
Product Code	ITY
Date Received	1997-02-26
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	2 MO
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	72414
Manufacturer	FISHER IMAGING CORP.
Manufacturer Address	12300 N. GRANT ST. DENVER CO 80241 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-02-26