FDA.reportPublic FDA data

MAUDE MDR 9905277

MDR report key
9905277
Report number
1219930-2020-01451
Event key
0
Event type
3
Date of event
2019-10-28
Date received
2020-03-31
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
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. THE HANDLE LOG WAS EVALUATED AND IT WAS DETERMINED THAT THERE WAS A ONE WIRE ERROR WHICH CAUSED THE DEVICE TO BE SET TO 0 REMAINING USES. 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. HOWEVER, SOFTWARE ERROR WAS IDENTIFIED DURING PRODUCT ANALYSIS. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A SOFTWARE ISSUE. IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS CONDITION. ADDITIONALLY, THE INVESTIGATION DETECTED A UNREPORTED CONDITION OF A VENTED BATTERY THAT HAS NO RELATIONSHIP TO THE REPORTED CONDITION. THE ROOT CAUSE OF THIS 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, PRIOR TO A PROCEDURE, THE HANDLE WAS REMOVED FROM THE CHARGER AND IT DISPLAYED ZERO FOR PROCEDURE. FIVE DAYS AGO, THE PROCEDURE REMAINING WAS CHECKED AND IT WAS 210. THERE WAS NO PATIENT INVOLVED.