FDA.reportPublic FDA data

MAUDE MDR 5901637

MDR report key
5901637
Report number
2134070-2016-00061
Event key
0
Event type
3
Date of event
2016-07-27
Date received
2016-08-24
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.NLMETH2B5LTETH2B5LT1917834Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-240

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 DURING A PROCEDURE, DEBRIS WAS FOUND IN TWO TROCARS. IT WAS REPORTED THAT NO ADVERSE EVENTS EXPERIENCED AND NO PATIENT INJURY OR CONSEQUENCES WERE NOTED. (SEE MFR REPORT# 2134070-2016-00060 AS THE FIRST DEVICE WAS REPORTED).

N

Patient 1

THE DEVICE WAS RETURNED TO THE MANUFACTURER AND EXAMINED. A SINGLE PIECE OF DEBRIS WAS ABLE TO BE EXTRACTED FROM THE INSIDE OF THE CANNULATED OBTURATOR. THE DEBRIS WAS FOUND TO BE DARK IN COLOR, THOUGH IT DID NOT EXHIBIT CHARACTERISTICS OF ORGANIC DEBRIS. AS THE ATTACHED IMAGES SHOW THE DEBRIS CURLS UPON ITSELF INSTEAD OF BREAKING OR FLAKING APART. THE DEBRIS'S ORIGIN IS UNKNOWN, THOUGH IT MAY HAVE BEEN KNOCKED LOOSE OR CUT LOOSE FROM THE BLACK PLASTIC THAT COMPOSES THE HANDLE OF THE OBTURATOR WHEN THE DEVICE WAS USED IN THE FIELD. BASED UPON THE APPEARANCE OF THE DEBRIS, IT IS LIKELY THE SAME DEBRIS THAT THE ACCOUNT PHOTOGRAPHED IN ITS ATTACHMENTS TO THIS COMPLAINT.