FDA.reportPublic FDA data

MAUDE MDR 9568493

MDR report key
9568493
Report number
1320894-2019-00438
Event key
0
Event type
3
Date of event
2019-12-13
Date received
2020-01-09
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
MELANIE LANNON
Address
11311 CONCEPT BOULEVARD LARGO FL 33773 US
Phone
727-727-7273
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NAKAQ SPIDER NET RETRIEVAL DEVICESTANDARD NETCONMED CORPORATIONFGX00230AUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-090

Event Narratives#

N

Patient 1

THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED. THEREFORE, THE REPORTED FAILURE CANNOT BE VERIFIED. A LOT NUMBER WAS NOT PROVIDED; THEREFORE, A COMPLAINT LOT HISTORY OR A DHR COULD NOT BE REVIEWED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 6 COMPLAINTS REGARDING 13 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; DO NOT USE THIS DEVICE IF THERE IS ANY DETECTABLE HANDLING OR SHIPPING DAMAGE. SLOWLY TEST DEPLOY NET BY SLIDING THUMB RING AND FINGER RINGS APART. INSPECT THE NET FOR DAMAGE. KEEPING THE OBJECT WITHIN THE NET, SLOWLY CLOSE THE NET BY SLIDING THE FINGER AND THUMB RINGS TOGETHER UNTIL THE NET FORMS A POUCH AROUND THE TARGET OBJECT. USE LIGHT TENSION ON THE THUMB AND FINGER RINGS TO ENSURE JUST ENOUGH PRESSURE TO MAINTAIN THE POUCH, THEREBY KEEPING THE OBJECT IN THE NET. DO NOT PERFORM A COMPLETE RETRACTION VIA THE SPECIMEN PROTECTION COLLAR, AS THIS WILL CRUSH THE SPECIMEN AND POSSIBLY DAMAGE THE NET AND/OR SHEATH. DO NOT ATTEMPT TO RETRACT THE OBJECT INTO THE WORKING CHANNEL OF THE ENDOSCOPE AS THIS WILL CRUSH THE SPECIMEN AND POSSIBLY DAMAGE THE NET SHEATH AND/OR ENDOSCOPE.

D

Patient 1

THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE 00230A, STANDARD NET, BROKE DURING A PEG (PERCUTANEOUS ENDOSCOPIC GASTRONOMY) TUBE REPLACEMENT PROCEDURE ON (B)(6) 2019. THE TETHERED PART OF THE NET WAS DETACHED FROM THE WIRE OF THE DEVICE. THE PRESSURE APPLIED OUTWEIGHED THE ULTIMATE TENSILE STRENGTH OF THE DEVICE. WHAT WAS LEFT OF THE NET WAS WRAPPED AROUND THE OBJECT THEY WERE TRYING TO RETRIEVE. THIS ALLOWED THEM TO CAPTURE THE REMAINING PARTS OF THE NET AND OBJECT TOGETHER. ANOTHER NET WAS USED TO COMPLETE THE SURGERY. THERE WAS A DELAY IN THE PROCEDURE TO GET ANOTHER NET. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY.