NEW LIGASURE 5MM LF1537

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-18 for NEW LIGASURE 5MM LF1537 manufactured by Covidien Lp.

Event Text Entries

[39006732] (b)(4). The sample has been requested but to date the incident sample has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[39006733] The customer reported that the jaws of the device would no longer open. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5


[45241873] (b)(4). Date of initial report: (b)(6) 2016. Date of follow-up report: (b)(6) 2016. One used lf1537 was received for evaluation, and examination of the returned device could not confirm the reported issue of difficulty opening. The device was not latched shut when received and the jaws would open normally. However, an alternative issue was identified where the device could not be latched shut. Further examination found this to be due to broken components within the handle. The ski guide appears to have caught on the internal track and the tabs, breaking the tabs that lock the latch. Investigation of this issue could not reliably determine the cause of the event. Review of the device history records for this lot shows no potentially contributing factors, and that it was released after meeting all quality specifications.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1717344-2016-00151
MDR Report Key5444844
Date Received2016-02-18
Date of Report2016-01-26
Date Mfgr Received2016-05-02
Device Manufacturer Date2015-02-20
Date Added to Maude2016-02-18
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 ContactMS. SHARON MURPHY
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925267
Manufacturer G1COVIDIEN LP
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal Code80301
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEW LIGASURE 5MM
Generic NameLIGASURE VESSEL SEALING SYSTEM
Product CodeBWA
Date Received2016-02-18
Returned To Mfg2016-03-30
Model NumberLF1537
Catalog NumberLF1537
Lot Number50160223X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP
Manufacturer Address5920 LONGBOW DRIVE BOULDER CO 80301 US 80301


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-18

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