FDA.reportPublic FDA data

MAUDE MDR 2123529

MDR report key
2123529
Report number
8010047-2011-00118
Event key
0
Event type
3
Date of event
2011-05-11
Date received
2011-06-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
LAURA STORMS-TYLER
Address
2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone
484-484-4848
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OLYMPUS TRACHEAL INTUBATION FIBERSCOPETRACHEAL INTUBATION FIBERSCOPEOLYMPUS MEDICAL SYSTEM CORPORATIONEQNLF-GPUNKNOWNNAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-06-090

Event Narratives#

D

Patient 1

OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE TIP OF THE SUBJECT DEVICE FELL INTO THE PATIENT. THE TIP WAS REPORTEDLY SUCTIONED OUT FROM THE PATIENT. THE PATIENT WAS REPORTEDLY UNHARMED.

N

Patient 1

OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT BUT WAS NOT PROVIDED ANY FURTHER INFORMATION. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. APPROXIMATELY 30MM OF THE INSERTION TUBE HAD BEEN TORN OFF FROM THE DISTAL END. INTERNAL ELEMENTS OF THE ENDOSCOPE, INCLUDING LIGHT GUIDE CABLE IN INSTRUMENT CHANNEL, WERE EXPOSED AT THE END OF THE INSERTION TUBE THAT REMAINED CONNECTED TO THE CONTROL BODY. ADDITIONALLY, THE BENDING SECTION SKELETON WAS NOTED DEFORMED, AND THE INSERTION TUBE WAS DENTED AND BUCKLED. BASED UPON THE FINDINGS OF THE INVESTIGATION, IT APPEARS THAT THE DISTAL END OF THE DEVICE WAS TORN FROM THE INSERTION TUBE, LIKELY WHEN THE ENDOSCOPE BECAME ENTRAPPED ON SOME UNKNOWN OBJECT AND WAS SUBJECTED TO EXTREME PHYSICAL FORCE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.