FDA.reportPublic FDA data

MAUDE MDR 5360515

MDR report key
5360515
Report number
1717344-2016-00032
Event key
0
Event type
3
Date of event
2015-12-23
Date received
2016-01-12
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
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 LPBWALF1537LF153750160221XY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-01-120

Event Narratives#

N

Patient 1

(B)(4). 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 DURING THE PROCEDURE, THE DEVICE JAWS COULD NOT BE RE-OPENED. THE SURGEON MANUALLY OPENED THE JAWS AND REPORTED THAT THE HANDLE JOINT WAS BROKEN. THERE WAS NO PATIENT INJURY.

N

Patient 1

(B)(4). ONE USED LF1537 DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION AND TESTING OF THE DEVICE CONFIRMED THAT THE LATCH WAS CLOSED AND WOULD NOT OPEN. THE DEVICE WAS ALSO FOUND TO HAVE SIGNS OF HARSH USE OR ABRASIVE CLEANING METHODS, INCLUDING BLEACHED WHITE JAWS. FURTHER INSPECTION CONFIRMED THAT THE LATCH WITHIN THE DEVICE IS BROKEN, CAUSING THE HANDLE TO LOCK INSTEAD OF OPEN. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS ITEM FOUND NO POTENTIALLY CONTRIBUTING ENTRIES, AND NO TREND IS ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION IDENTIFIED THE LIKELY ROOT CAUSE AS MISUSE BY THE CUSTOMER, WHERE ROUGH USE OR HARSH CLEANING METHODS CONTRIBUTED TO DEVICE BREAKAGE.