FDA.reportPublic FDA data

MAUDE MDR 5444844

MDR report key
5444844
Report number
1717344-2016-00151
Event key
0
Event type
3
Date received
2016-02-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. SHARON MURPHY
Address
5920 LONGBOW DRIVE BOULDER CO 80301 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEW LIGASURE 5MMLIGASURE VESSEL SEALING SYSTEMCOVIDIEN LPBWALF1537LF153750160223XY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-180

Event Narratives#

N

Patient 1

(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.

D

Patient 1

THE CUSTOMER REPORTED THAT THE JAWS OF THE DEVICE WOULD NO LONGER OPEN. THERE WAS NO INJURY TO THE PATIENT.

N

Patient 1

(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.