FDA.reportPublic FDA data

MAUDE MDR 4586387

MDR report key
4586387
Report number
1423253-2015-00002
Event key
0
Event type
3
Date of event
2015-02-19
Date received
2015-03-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LAURA MEYER
Phone
847-847-8473
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1E.CAMGAMMA CAMERASIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUPIYX4380221Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-0601. R

Event Narratives#

D

Patient 1

CUSTOMER NARRATIVE: "CUSTOMER WAS INSTALLING MEDIUM ENERGY COLLIMATOR ON HEAD ONE, HEAD 2 ALIGNED, HEAD ON CART NOT ALIGNED, CUSTOMER PUSHED COLLIMATOR ON HALFWAY, REALIZED COLLIMATOR NOT ON TRACK, ATTEMPTED TO PULL COLLIMATOR BACK OFF, COLLIMATOR FELL ON RIGHT HAND." MFR NARRATIVE: THE OPERATOR OF THE E.CAM GAMMA CAMERA NUCLEAR MEDICINE SYSTEM WAS IN THE PROCESS OF CHANGING THE COLLIMATORS (ACCESSORY) PRIOR TO USE OF THE E.CAM SYSTEM. THERE WAS A MISALIGNMENT, WHICH DID NOT ALLOW THE PROPER CHANGE OF THE COLLIMATOR; HOWEVER, THE CUSTOMER CONTINUED TO PERFORM THE COLLIMATOR CHANGE RESULTING IN THE COLLIMATOR FALLING AND IMPACTING THE RIGHT HAND OF THE OPERATOR. A MISALIGNED COLLIMATOR EXCHANGE SHOULD NOT BE ATTEMPTED. FOLLOWING THE LABELING INSTRUCTIONS FOR COLLIMATOR CHANGE WOULD REDUCE THE POTENTIAL FOR INJURY OR DAMAGE TO THE SYSTEM. IN THIS CASE, THE CUSTOMER CHOSE TO ATTEMPT TO CHANGE THE COLLIMATOR DESPITE THE MISALIGNMENT ISSUE, WHICH RESULTED IN THE FALL OF THE COLLIMATOR AND INJURY. THE OPERATOR INJURY CONSISTED OF A BROKEN FINGER AND CUT THAT REQUIRED AN UNDISCLOSED NUMBER OF STITCHES. THERE WAS NO PT INVOLVED IN THE EVENT AND THE INCIDENT ONLY INVOLVED THE OPERATOR OF THE DEVICE.

N

Patient 1

(B)(6). DURING A REVIEW OF FILES WE DETERMINED THAT THE PATIENT IDENTIFIER SUBMITTED WITH THE ORIGINAL FORM FDA 3500A WAS INCORRECT. THIS SUPPLEMENT CORRECTS THE PATIENT IDENTIFIER (ICD).

N

Patient 1

THIS SUPPLEMENT IS BEING SUBMITTED TO CORRECT "DATE OF EVENT". DURING FOLLOW-UPS ON THIS COMPLAINT, WE BECAME AWARE ON 06/22/2015 THAT THE REPORTED DATE OF EVENT (02/18/2015) WAS INCORRECT. THE CORRECT DATE OF EVENT ((B)(6) 2015) IS BEING SUBMITTED VIA THIS SUPPLEMENT REPORT.