FDA.reportPublic FDA data

MAUDE MDR 9693749

MDR report key
9693749
Report number
9693749
Event key
0
Event type
3
Date of event
2019-11-12
Date received
2020-02-11
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHARKCOREBIOPSY NEEDLECOVIDIEN LPFCGDSC-22-01DSC-22-01B000000881* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-110

Event Narratives#

D

Patient 1

DR MADE ONE PASS WITH FNB NEEDLE WITHOUT PROBLEM. DURING THE SECOND PASS, THE NEEDLE WOULD NOT ADVANCE. STAFF REMOVED THE NEEDLE FROM THE SCOPE AND THE NEEDLE ADVANCED. NEEDLE WAS REINSERTED AND THE NEEDLE WOULD NOT ADVANCE WHEN IN THE SCOPE. A NEW NEEDLE WAS OPENED AND WAS USED WITHOUT PROBLEM AND NO HARM CAME TO THE PATIENT. THE REP WAS NOTIFIED BY STAFF. MANUFACTURER RESPONSE FOR BIOPSY NEEDLE, SHARKCORE (PER SITE REPORTER). DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. AWAITING REPLY FROM MANUFACTURER.