SIGNIA SIGPHANDLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-31 for SIGNIA SIGPHANDLE manufactured by Covidien Lp Llc North Haven.

Event Text Entries

[185803371] 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.
Patient Sequence No: 1, Text Type: N, H10


[185803372] According to the reporter, during a distal pancreatectomy, after the handle was inserted into the shell during set up, the display was checked and it was found to be blackout. The event occurred during the procedure but the product was not used for patient. The procedure was completed with another device. No patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219930-2020-01445
MDR Report Key9904622
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-09-27
Date Mfgr Received2020-03-12
Device Manufacturer Date2018-01-08
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN LP LLC NORTH HAVEN
Manufacturer Street195 MCDERMOTT RD
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal Code06473
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIGNIA
Generic NameSTAPLE, IMPLANTABLE
Product CodeGDW
Date Received2020-03-31
Returned To Mfg2019-10-22
Model NumberSIGPHANDLE
Catalog NumberSIGPHANDLE
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP LLC NORTH HAVEN
Manufacturer Address195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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