FDA.reportPublic FDA data

MAUDE MDR 2675906

MDR report key
2675906
Report number
1045254-2012-00403
Event key
0
Event type
3
Date of event
2012-07-10
Date received
2012-07-31
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
RAHN GREENE
Address
6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US
Phone
904-904-9043
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ELEVATOR 3714040 WOODSON DBL 10/30DEGELEVATOR, ENTXOMED MICRO-FRANCE MFGKAD37140403714040NOT PROVIDEDN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-07-3101. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A SCHEDULED PROCEDURE THE SURGEON WAS USING THE INSTRUMENT AND THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT. THEY RETRIEVED THE FRAGMENTS. AN X RAY WAS DONE TO ENSURE NO FRAGMENTS WERE LEFT IN THE PATIENT CAUSING A 20 - 30 MINUTE DELAY. THERE WAS NO REPORTED PATIENT INJURY.

N

Patient 1

(B)(4). THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. METHOD/RESULTS: THE PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. THIS DEVICE IS USED FOR TREATMENT PURPOSES. BLANK FIELDS IN THIS REPORT ARE A RESULT OF INFORMATION NOT PROVIDED BY THE PHYSICIAN AND/OR USER FACILITY. DEVICE DESCRIPTION: AN EAR, NOSE, AND THROAT MANUAL SURGICAL INSTRUMENT IS ONE OF A VARIETY OF DEVICES INTENDED FOR USE IN SURGICAL PROCEDURES TO EXAMINE OR TREAT THE BRONCHUS, ESOPHAGUS, TRACHEA, LARYNX, PHARYNX, NASAL AND PARANASAL SINUS, OR EAR. IT IS THE RESPONSIBILITY OF THE SURGICAL TEAM TO SELECT THE APPROPRIATE INSTRUMENT FOR EACH CASE AND CHECK THE CONDITION OF INSTRUMENTS BEFORE AND AFTER EACH CASE. REMOVE FROM USE ANY INCOMPLETE OR POORLY OPERATING INSTRUMENTS. DO NOT BEND, PRY, OR USE EXCESSIVE FORCE, BREAKAGE OR FAILURE OF THE INSTRUMENT COULD OCCUR RESULTING IN POSSIBLE HARM TO THE PATIENT OR USER. INSPECT COMPONENTS FOR ANY DAMAGE BEFORE AND AFTER EACH USE. IF DAMAGE IS OBSERVED DO NOT USE THE INSTRUMENT UNTIL IT IS REPAIRED. AFTER CLEANING AND STERILIZATION, VERIFY FUNCTIONALITY PRIOR TO RE-USE.