FDA.reportPublic FDA data

MAUDE MDR 16465

MDR report key
16465
Report number
MW1003523
Event key
0
Event type
3
Date of event
1994-09-06
Date received
1994-09-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KLEPPINGER FORCEPSRICHARD WOLF MEDICAL INSTRUMENT CORP.FJR8383.21.1, 8384.21.1NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-09-280

Event Narratives#

D

Patient 1

THE FORCEPS IS ATTACHED TO A BIPOLAR CORD AT THE BACK OF THE INSTRUMENT. THE PROCEDURE IS PERFORMED. THEN, WHEN THE CORD IS REMOVED FROM THE FORCEPS FOR CLEANING, PART OF THE FORCEPS BREAKS OFF AND REMAINS STUCK INSIDE THE BIPOLAR CORD. IT COSTS THE FACILITY $658.00 TO REPLACE THE TWO ITEMS. (SEE ALSO 1003524.)