FDA.reportPublic FDA data

MAUDE MDR 8471167

MDR report key
8471167
Report number
1320894-2019-00089
Event key
0
Event type
3
Date received
2019-04-01
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
MR. JOHN BERGA
Address
11311 CONCEPT BLVD. LARGO FL 33773 US
Phone
727-727-7273
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STANDARD NET 230L 10 PACKSNARE, NON-ELECTRICALCONMED CORPORATIONFGX00230A201808131R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-0101. O

Event Narratives#

N

Patient 1

THE ALLEGED BROKEN 00230A IS NOT EXPECTED TO BE RETURNED FOR EVALUATION OR REVIEW AND NO PHOTOGRAPHIC EVIDENCE WAS SUPPLIED. THIS COMPLAINT OF BROKEN DEVICE IS UNABLE TO BE VERIFIED AND A ROOT CAUSE CANNOT BE DETERMINED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE HAVE BEEN TWO COMPLAINTS FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS; HOWEVER, NONE OF THESE COMPLAINTS HAVE BEEN CONFIRMED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 12 COMPLAINTS, REGARDING (B)(4) DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: CONTRAINDICATIONS: THIS DEVICE IS NOT INTENDED TO BE USED FOR SEVERING TISSUE OR POLYPS AND IS NOT INTENDED TO BE CONNECTED TO AN ELECTROSURGICAL DEVICE TO PROVIDE CAUTERY. THIS DEVICE IS NOT MRI COMPATIBLE. WARNING: THIS DEVICE IS NOT RECOMMENDED FOR THE CAPTURE OF SHARP OBJECTS. WHEN CAPTURING FOREIGN BODIES AND POLYPS, BE SURE TO AVOID CAPTURING MUCOSA OR ANATOMY NOT INTENDED FOR RETRIEVAL. WHEN RETRIEVING OBJECTS THROUGH THE ESOPHAGUS, BE SURE TO KEEP GENTLE TENSION ON THE DEVICE HANDLE TO AVOID DISLODGEMENT, LOSS OF OBJECT AND/OR ASPIRATION INTO THE TRACHEA. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

D

Patient 1

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00230A, STANDARD NET 230L, 10 PACK, DEVICE "WHEN THE PIECES OF POLYP WERE IN THE NETS, THE NET APPEARED TO START TO DISINTEGRATE AND THEN FELL OFF THE WIRE. NO, THEY DID NOT KEEP THE NETS. PART OF IT DID COME OFF, WHEN I (ACCOUNT CONTACT) WENT INTO THE PROCEDURE ROOM YOU COULD SEE SOME OF THE FIBERS ADHERING TO THE POLYP WHICH WAS STILL IN THE COLON". FURTHER INFORMATION WAS REQUESTED; HOWEVER, THE SALES REPRESENTATIVE ADVISED THE ACCOUNT WISHED TO HAVE NO FURTHER CONTACT. IT IS UNKNOWN IF ALL COMPONENTS WERE REMOVED FROM THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE UNKNOWN RETRIEVAL OF ALL COMPONENTS OF THE DEVICE.