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Adverse Event Report

ELGEMS LTD APEX VARICAM GAMMA CAMERA   back to search results
Catalog Number 100-3100-0101
Device Problems Power, loss of; Repair
Event Date 07/21/1998
Patient Outcome  Required Intervention;
Event Description

Service engineer was working on the varicam system with power off. The motor drive was released to gain better access to a panel to change a fuse. The heads were left in the "l position" instead on the "h position" as outlined by the mfr's technical notice. The weight of the gantry allowed the gear to move. The engineer's two fingers of the right hand were wedged between the main gear and the gear box. Both finger nails were ripped off and there may be come tendon damage. Both finger nails were re-attached in the er and stitched.

 
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Brand NameAPEX VARICAM
Type of DeviceGAMMA CAMERA
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ELGEMS LTD
po box 170
tirat hacarmel
ISRAEL 30200
Manufacturer (Section D)
ELGEMS LTD
po box 170
tirat hacarmel
ISRAEL 30200
Device Event Key177246
MDR Report Key182303
Event Key171372
Report Number182303
Device Sequence Number1
Product CodeIYX
Report Source Distributor
Reporter Occupation Service Personnel
Type of Report Initial
Report Date 08/07/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device Catalogue Number100-3100-0101
OTHER Device ID NumberTAG#58363
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/31/1998
Distributor Facility Aware Date07/22/1998
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer07/27/1998
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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