FDA.reportPublic FDA data

MAUDE MDR 9904811

MDR report key
9904811
Report number
1219930-2020-01447
Event key
0
Event type
3
Date of event
2019-10-11
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA HERNANDEZ
Address
60 MIDDLETOWN AVE. NORTH HAVEN CT 06473 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SIGNIASTAPLE, IMPLANTABLECOVIDIEN LP LLC NORTH HAVENGDWSIGPHANDLESIGPHANDLEY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. AN ANALYSIS OF THE SYSTEM LOGS NOTED THAT TOWARDS THE END OF THE LOGS, THE HANDLE WAS PLACED ON A CHARGER. THE NEXT TIME THE HANDLE INITIALIZES IS WITH LOW VOLTAGE DETECTED ON THE CHARGER, A LOW RELATIVE STATE OF CHARGE VALUE, AND LOW INDIVIDUAL CELL VOLTAGES. THE HANDLE WAS OPENED UP AND BOTH BATTERIES WERE FOUND TO BE VENTED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A SOFTWARE FAULT. THE BATTERY CELLS VENTED, CAUSING THEM TO LEAK ELECTROLYTIC FLUID. THE BATTERY CELLS WOULD BE UNABLE TO CHARGE UNDER THESE CIRCUMSTANCES AND WOULD RESULT IN THE HANDLE ENTERING A CELL UNDER VOLTAGE STATE. IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY, DURING THE FIRST FIRING, THE HANDLE WAS REMOVED FROM THE CHARGER FOR THE PATIENT USE. THE POWER HANDLE DID NOT START UP, SO IT WAS REINSERTED INTO THE BATTERY CHARGER BUT THE SAME SITUATION CONTINUED, THEREFORE IT WAS EXCHANGED TO DIFFERENT HANDLE TO RESOLVE THE ISSUE. THE SALES REP VISITED THE FACILITY AND CHECKED THE HANDLE AND THE CHARGER. BURNT TRACES AND VISCOUS LIQUID WERE FOUND TO BE ADHERED TO THE ELECTRODE PART. SALES REP WIPED THE LIQUID OUT CLEANLY AND INSERTED THE HANDLE INTO THE CHARGER BUT THE SITUATION DID NOT IMPROVE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. NO PATIENT INJURY.