FDA.reportPublic FDA data

MAUDE MDR 7419845

MDR report key
7419845
Report number
2951238-2018-00236
Event key
0
Event type
3
Date received
2018-04-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CONNIE TUBERA
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
1ENDOSCOPE MODEL 160UNKNOWNOLYMPUS MEDICAL SYSTEMS CORP.NWBUNKNOWNUNKNOWNR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-1001. O

Event Narratives#

N

Patient 1

AS PART OF OUR INVESTIGATION, OLYMPUS MADE MULTIPLE FOLLOW UPS WITH THE USER FACILITY BY TELEPHONE AND IN WRITING IN AN ATTEMPT TO GATHER ADDITIONAL INFORMATION ON THE REPORTED EVENT; HOWEVER, LIMITED INFORMATION WAS OBTAINED. THE USER FACILITY REPORTED THAT THIS EVENT WAS MENTIONED DURING A MARKET RESEARCH AND UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION BEYOND WHAT HAS BEEN REPORTED. SINCE NO MODEL OR SERIAL NUMBER WAS PROVIDED, OLYMPUS WAS UNABLE TO PERFORM A DEVICE SERVICE HISTORY REVIEW. THEREFORE, THE CAUSE OF THE REPORTED PATIENT INFECTION COULD NOT BE CONCLUSIVELY DETERMINED.

D

Patient 1

OLYMPUS WAS INFORMED THAT AN UNSPECIFIED OLYMPUS 160 MODEL ENDOSCOPE WAS FOUND LEAKING ON THE CONTROL BUTTONS (EXACT BUTTONS UNKNOWN) DURING AN UNSPECIFIED PROCEDURE, AND THE PATIENT CONTRACTED A STOMACH INFECTION. IT IS UNKNOWN IF THE LEAKING SCOPE CAUSED THE INFECTION OR IF THE REPROCESSING OF THE SCOPE WAS THE CAUSE. A DIFFERENT SCOPE WAS USED TO COMPLETE THE PROCEDURE.