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MAUDE MDR 135349

MDR report key
135349
Report number
1418479-1997-00060
Event key
0
Event type
3
Date of event
1997-10-08
Date received
1997-11-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HULKA TENACULUM FORCEPUTERINE TENACULUM FORCEPRICHARD WOLF GMBHHCZ8371.008371.00A-F-PNYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11997-11-240

Event Narratives#

D

Patient 1

A TUBAL LIGATION PROCEDURE WAS IN PROGRESS WHEN THE TENACULUM FORCEP, FOR MANIPULATING THE UTERUS, BROKE. A SECTION OF THE METAL TIP, MEASURING APPROXIMATELY 35MM IN LENGTH, BROKE OFF AND REMAINED IN THE UTERUS. THE PIECE WAS REMOVED WITH A GRASPING FORCEPS WITH NO REPORTED PROBLEMS FOR THE PT.