FDA.reportPublic FDA data

MAUDE MDR 6041356

MDR report key
6041356
Report number
2134070-2016-00074
Event key
0
Event type
3
Date of event
2016-08-12
Date received
2016-10-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JASON ANDERSON
Address
5010 CHESHIRE PARKWAY SUITE 2 PLYMOUTH MN 55446 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSEDSTERILMED, INC.NONMIC1332MIC13321942933Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-190

Event Narratives#

N

Patient 1

THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A SUPPLEMENTAL FORM WILL BE SENT ONCE THE EVALUATION IS COMPLETED IF THE DEVICE IS RETURNED. THE DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.

D

Patient 1

IT WAS REPORTED THAT THE DEVICE WAS TESTED BY OPENING AND CLOSING PRIOR TO PLACING IT IN THE SCOPE. UPON OPENING, WHILE IN THE PATIENT TO RETRIEVE A BIOPSY, THE DEVICE BROKE. IT WAS NOTED THAT NO FRAGMENTS OR PIECES WERE LEFT IN THE PATIENT. IT WAS REPORTED THAT THERE WAS NO HARM DETECTED TO THE PATIENT.

N

Patient 1

THE BIOPSY FORCEPS WERE RETURNED WITH A CLEARLY DAMAGED JAW, AND A PORTION OF THE MECHANISM THAT OPENS AND CLOSES THE JAW WAS OUT OF POSITION. THE DEVICE WAS EXAMINED AND CONTAMINANTS CONSISTENT WITH EXPOSURE, IF NOT USE, WERE FOUND TO BE PRESENT. THE DEVICE WAS ABLE TO OPEN AND CLOSE WITHOUT ISSUE. THE ROOT CAUSE FOR THE DAMAGE WAS UNDETERMINED, HOWEVER, AS THE DEVICE WAS USED IN THE FIELD, THE DEVICE MAY HAVE BEEN MISHANDLED OR DAMAGED DURING ITS USE