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MAUDE MDR 3599468

MDR report key
3599468
Report number
MW5034043
Event key
0
Event type
3
Date of event
2014-01-15
Date received
2014-01-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GYN FORCEPSSEMI-RIGID ALLIGATOR GRASPEROLYMPUSHCZGYA 5

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-2301. O

Event Narratives#

D

Patient 1

ON (B)(6) 2014: FEMALE PT WHO UNDERWENT OUTPATIENT LAPAROSCOPIC TUBAL LIGATION, DILATION AND CURETTAGE AND HYSTEROSCOPY, NOVASURE AND REMOVAL OF PARAGARD INTRAUTERINE DEVICE (IUD). AFTER MULTIPLE REPEATED/UNSUCCESSFUL ATTEMPTS TO REMOVE THE IUD, SURGEON DECIDED TO USE AN OPERATIVE SCOPE AND GRASPER TO OBTAIN IUD. IN THE PROCESS OF "GRABBING IT" WITH THE GRASPER, A PORTION OF THE TIP (APPROX 0.5 CM X 2.7.) OF THE GRASPER BROKE AND WAS WITHIN THE PT. XRAY WAS OBTAINED AND CONFIRMED THAT THE TIP/METAL PIECE REMAINED IN PT'S UTERUS. UTILIZING A HYSTEROSCOPY THE METAL TIP WAS FOUND AND REMOVED FROM PT. SURGERY WAS COMPLETED AND PT SENT TO RECOVERY ON (B)(6) 2013 - POST RECOVERY PT WAS DISCHARGED HOME IN STABLE CONDITION.