FDA.reportPublic FDA data

MAUDE MDR 5392567

MDR report key
5392567
Report number
1717344-2016-00072
Event key
0
Event type
3
Date of event
2016-01-19
Date received
2016-01-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
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
1ULTRASONIC DISSECTORULTRASONIC DISSECTORCOVIDIEN LPBWASCD396SCD39641680113XY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-01-270

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, A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED DURING THE CLEANING OF THE JAWS WITH GAUZE. NOTHING FELL INTO THE PATIENT CAVITY AND THERE WAS NO PATIENT INJURY..

N

Patient 1

(B)(4). ONE USED SONICISION CORDLESS ULTRASONIC DISSECTOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DISPOSABLE HAND PIECE REVEALED THAT THE WAVEGUIDE HAD FRACTURED AND THE TIP HAD BROKEN OFF. THE BROKEN TIP DID NOT FALL INTO CAVITY BUT WAS NOT RETURNED. THE REPORTED CONDITION WAS CONFIRMED. THE WAVEGUIDE WAS INSPECTED UNDER MAGNIFICATION TO IDENTIFY THE POINT OF INITIAL CONTACT THAT CAUSED THE FRACTURE AND EVENTUAL BREAK. INVESTIGATION PERSONNEL CONCLUDED THAT THE TITANIUM WAVEGUIDE WAS IN USE WHEN IT FRACTURED. FURTHER INVESTIGATION REVEALED THAT THE DISSECTOR TIP CAME IN CONTACT WITH A METAL OBJECT (HEMOSTATS, CLIPS, STAPLES, RETRACTORS, ETC.) DURING ACTIVATION. THIS CONTACT CAUSED THE WAVEGUIDE TO CRACK AND EVENTUALLY BREAK OFF. THE INVESTIGATION IDENTIFIED THE CAUSE OF THE REPORTED EVENT TO BE USER ERROR. THE DEVICE INSTRUCTIONS FOR USE CURRENTLY CONTAIN A WARNING AGAINST CONTACT BETWEEN THE DISSECTOR TIP AND METAL OBJECTS (HEMOSTATS, CLIPS, STAPLES, RETRACTORS, ETC.) DURING ACTIVATION. THIS ISSUE IS SPECIFIC TO ULTRASONIC DISSECTORS.