FDA.reportPublic FDA data

MAUDE MDR 158410

MDR report key
158410
Report number
2124979-1998-00002
Event key
0
Event type
3
Date of event
1998-02-27
Date received
1998-03-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BERKELEY VACURETTE 8MM F-SETFLEXIBLE TIP VACURETTECIRCON SURGITEKHHKNA531584D1031NRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11998-03-170

Event Narratives#

N

Patient 1

AN INSPECTION OF THE DEVICE ASSOCIATED WITH THE INCIDENT WAS CONDUCTED. THE DISTAL TIP OF THE DEVICE WAS NOT RETURNED. THE PORTION OF THE DEVICE THAT WAS RETURNED WAS TORN AT THE POINT BETWEEN THE DISTAL AND PROXIMAL SUCTION PORTS. THE TEAR APPEARS TO HAVE STARTED AT THE SHARP POINT OF THE PROXIMAL SUCTION PORT AND PROPAGATED THROUGH THE VACURETTE TO THE BOTTOM OF THE DISTAL SUCTION PORT. THIS IS THE THINNIST POINT OF THE DEVICE CROSS-SECTION. THERE WERE NO SIGNS OF CUTTING OR MELTING OF THE DEVICE. THE DEVICE HAS YELLOWED OR BECOME BRITTLE AND ALL OTHER ASPECTS OF THE UNIT HAVE REMAINED UNCHANGED. IN ADDITION TO THE VISUAL EXAMINATION OF THE RETURNED DEVICE, PULL STRENGTH TESTING OF THE SUCTION PORTS OF THE 8 MM F-TIP WAS PERFORMED ON PRODUCT IN INVENTORY. THE RESULTS OF THIS TESTING SHOWED THE AVERAGE PULL STRENGTH FOR THE DISTAL PORT TO BE 14.14 LBS (ONE STANDARD DEVIATION = 1.64 LBS) AND THE AVERAGE PULL STRENGTH FOR THE PROXIMAL PORT TO BE 22.66 LBS (ONE STANDARD DEVIATION = 1.86 LBS). AN ILLUSTRATION OF THE DEVICE AND TEST CONFIGURATION IS INCLUDED IN THIS SUBMISSION.

D

Patient 1

WHEN PULLING THE F-TIP VACURETTE OUT OF THE UTERUS DURING A VACUUM CURRETAGE PROCEDURE, THE TIP GOT STUCK. THE DR PULLED HARDER AND WAS ABLE TO REMOVE THE F-TIP VACURETTE. WHEN THE VACURETTE WAS REMOVED FROM THE UTERUS IT WAS NOTED THAT THE TIP WAS MISSING. A D & C WAS PERFORMED AND THE TIP COULD NOT BE FOUND. IT IS ASSUMED THAT THE TIP IS EMBEDDED IN THE UTERUS.