FDA.reportPublic FDA data

MAUDE MDR 5500241

MDR report key
5500241
Report number
2951238-2016-00307
Event key
0
Event type
3
Date of event
2016-02-16
Date received
2016-03-15
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR DONNY SHAPIRO
Address
2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OLYMPUS ENDOSCOPEENDOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.GCMUNKNOWNUNKNOWNN/AR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-1501. D; 2. O

Event Narratives#

N

Patient 1

THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE PATIENT'S OUTCOME COULD NOT BE DETERMINED. AS PART OF OUR INVESTIGATION, OLYMPUS MADE MULTIPLE FOLLOW UPS TO GATHER ADDITIONAL INFORMATION REGARDING THE EVENT VIA TELEPHONE AND IN WRITING, BUT NO ADDITIONAL INFORMATION WAS OBTAINED.

D

Patient 1

OLYMPUS RECEIVED A LEGAL DOCUMENT ON FEBRUARY 17, 2016 WHICH ALLEGES THAT FOLLOWING THE ADMITTANCE OF A PATIENT IN (B)(6) 2014, THE PATIENT DEVELOPED MEDICAL CONDITIONS AFTER BEING EXAMINED BY AN UNSPECIFIED ENDOSCOPE. THE MEDICAL CONDITIONS INCLUDED: INFECTION, RENAL INSUFFICIENCY, RESPIRATORY INSUFFICIENCY, SEPSIS, CARDIAC ARREST, AND DEHYDRATION. THE PATIENT SUSTAINED INJURIES AS A RESULT OF A FALL, AND ULTIMATELY EXPIRED. THE CAUSE OF DEATH IS UNKNOWN.