CUSA EXCEL 23KHZ STANDARDTIP C4601S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-01-21 for CUSA EXCEL 23KHZ STANDARDTIP C4601S manufactured by Integra Lifesciences Ireland Limited.

Event Text Entries

[17569243] This is the second of three reports regarding c4601s - cusa excel 23khz. Standardtip (same reporter, same product id, same lot number, different pts). A new c4601s tip was used with a c2600 cusa handpiece during liver surgery. The user turned off the cusa excel main switch and then turned it on. The "test" button was pushed. Then, it was reported that the tip was broken in two parts after 10 minutes. The panel showed the tip alarm. Add'l info was requested from the distributor and on (b)(6) 2014, the following was provided: a (b)(6) year old male patient underwent liver surgery. The tip was not being used on the patient at the time it broke. The distributor did not know the circumstances of how the tip broke. The tip was not being used near or next to another metal instrument. There was no pt harm or injury. There was no surgical delay. A replacement tip was available to be used. It was reported that the tip has previously been used one time before.
Patient Sequence No: 1, Text Type: D, B5


[17714324] To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006697299-2014-00004
MDR Report Key3726591
Report Source01,08
Date Received2014-01-21
Date of Report2013-12-30
Date of Event2013-12-23
Date Mfgr Received2013-12-30
Date Added to Maude2014-05-06
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 FDA0
Event Location0
Manufacturer ContactROWENA BUNUAN
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA LIFESCIENCES IRELAND LIMITED
Manufacturer StreetIDA BUSINESS AND TECHNOLOGY PARK
Manufacturer CitySRAGH TULLAMORE 0000
Manufacturer Postal Code0000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCUSA EXCEL 23KHZ STANDARDTIP
Generic NameULTRASONIC SURGICAL PRODUCTS
Product CodeLBK
Date Received2014-01-21
Catalog NumberC4601S
Lot Number1125734
Device Expiration Date2015-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES IRELAND LIMITED
Manufacturer AddressIDA BUSINESS AND TECHNOLOGY PARK SRAGH TULLAMORE 0000 0000


Patients

Patient NumberTreatmentOutcomeDate
10 2014-01-21

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