LIGASURE LF1637

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-03 for LIGASURE LF1637 manufactured by Stryker Sustainability Solutions, Inc..

Event Text Entries

[122668844] A ligasure blunt tip laparoscopic sealer/divider 5mm x 37cm was opened to the field and connected to the ligasure unit. Dr. Attempted to use the unit when an error code came up reading as follows, "seal not complete, please attempt to seal device again. " dr. Attempted to reseal device and it did not work. Unit was disconnected and reconnected and still did not seal properly. A new device was opened and worked well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7929978
MDR Report Key7929978
Date Received2018-10-03
Date of Report2018-09-05
Date of Event2018-08-22
Report Date2018-09-05
Date Reported to FDA2018-09-05
Date Reported to Mfgr2018-09-21
Date Added to Maude2018-10-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIGASURE
Generic NameELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC
Product CodeNUJ
Date Received2018-10-03
Catalog NumberLF1637
Lot Number8603165
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER SUSTAINABILITY SOLUTIONS, INC.
Manufacturer Address1810 W. DRAKE DR. TEMPE AZ 85283 US 85283


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-03

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