FDA.reportPublic FDA data

MAUDE MDR 6385184

MDR report key
6385184
Report number
2134070-2017-00002
Event key
0
Event type
3
Date of event
2017-01-29
Date received
2017-03-07
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
1LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSEDSTERILMED, INC.NLMETHCB5LTETHCB5LT1961626Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-070

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 WHILE THE DEVICE WAS IN THE ABDOMEN, THE DEVICE HAD A SMALL PORTION OF THE TIP SPLIT OFF, NOT COMPLETELY SEPARATING FROM THE DEVICE. THE PIECE WAS COMPLETELY RETRIEVED .

N

Patient 1

THE DEVICE WAS RETURNED FOR EVALUATION AND WAS EXAMINED HAVING CONTAMINANTS FOUND THAT WERE CONSISTENT WITH PATIENT CONTACT AND USE IN THE FIELD. THE TIP OF THE DEVICE WAS EXAMINED UNDER MAGNIFICATION. THE MISSING PORTION WAS NOT RETURNED AND THEREFORE COULD NOT BE EXAMINED. THE DAMAGE TO THE TIP MAY HAVE BEEN CAUSED BY A HEATED INSTRUMENT BEING PRESSED AGAINST THE TIP AS THE DAMAGE IS JAGGED RATHER THAN SMOOTH, AS IF PARTIALLY MELTED. THE ROOT CAUSE WAS LIKELY LINKED TO THE USE AND POTENTIAL MISUSE OF THE DEVICE IN THE FIELD. IF A HEATED OR COAGULATING DEVICE MADE CONTACT WITH THE PLASTIC TIP OF THE DEVICE, THE TIP COULD HAVE BROKEN OFF DUE TO MISUSE. THERE ARE NO OTHER STRUCTURAL ANOMALIES PRESENT THAT INDICATE ANY ADDITIONAL SECTIONS OF THE DEVICE WERE DISPLACED/SEPARATED FROM THE SLEEVE.