FDA.reportPublic FDA data

MAUDE MDR 9769301

MDR report key
9769301
Report number
1320894-2020-00087
Event key
0
Event type
3
Date of event
2020-01-31
Date received
2020-02-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JOHN BERGA
Address
11311 CONCEPT BLVD. LARGO, FL US
Phone
399-399-3995
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
12020-02-280

Event Narratives#

N

Patient 1

THE ALLEGED BROKEN 00230A IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. 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 HAS BEEN TWO COMPLAINTS FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 5 COMPLAINTS, REGARDING 6 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 53,885 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 0.0001. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: WARNINGS: DO NOT USE THIS DEVICE IF THERE IS ANY DETECTABLE HANDLING OR SHIPPING DAMAGE. INSTRUCTIONS FOR USE: INSPECT THE PEEL-POUCH FOR ANY DAMAGE THAT MAY HAVE OCCURRED DURING TRANSIT OR HANDLING. IF DAMAGED, DO NOT USE. REMOVE THE NAKAO SPIDER-NET RETRIEVAL DEVICE FROM THE PEEL-POUCH AND INSPECT FOR KINKS, FRAYING WIRE, TORN NET OR ANY OTHER DAMAGE THAT MAY HAVE OCCURRED DURING TRANSIT. DO NOT USE IF THERE IS EVIDENCE OF DAMAGE. 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 DEVICE WAS BEING USED DURING THE REMOVAL OF A GASTROSTOMY TUBE VIA THE UPPER ESOPHAGEAL SPHINCTER ON (B)(6) 2020 WHEN THE NET BROKE UPON OPENING IN THE ESOPHAGUS. A SECOND DEVICE WAS USED AND IS REPORTED TO HAVE BROKEN. THE CAUSE OF THE BREAKAGE IS NOT KNOWN BY THE REPORTER. THERE WAS NO FRAGMENTATION FROM THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A 15-MINUTE DELAY USING ANOTHER SAME DEVICE. THERE WAS NO IMPACT TO THE PATIENT OR THE USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.