FDA.reportPublic FDA data

MAUDE MDR 6265575

MDR report key
6265575
Report number
8010047-2017-10039
Event key
0
Event type
3
Date of event
2011-06-08
Date received
2017-01-19
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
MR. SUSUMU NISHINA
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8 JA
Phone
426-426-4264
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROBEPROBEOLYMPUS MEDICAL SYSTEMS COOPERATIONFEOMAJ-984Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-01-1901. O

Event Narratives#

N

Patient 1

THE SUBJECT DEVICE WAS RETURNED TO OKM ((B)(6)) FOR INVESTIGATION. OKM INVESTIGATED THE SUBJECT DEVICE AND FOUND THAT THERE WAS FRICTION MARK OBSERVED ON THE SUBJECT DEVICE AND ON ANOTHER MAJ-984 USED DURING THE PROCEDURE. IT WAS REPORTED THAT THE FACILITY USED A NON-OLYMPUS NEPHROSCOPE WITH THE SUBJECT DEVICE. ACCORDING TO THE PICTURES FROM OKM, IT WAS FOUND THAT THE NON-OLYMPUS NEPHROSCOPE WAS BENT A LITTLE. FROM THE FACT THAT THE NEPHROSCOPE WAS BENT AND ITS CHANNEL WAS ALSO BENT, THE SUBJECT MAJ-984 MIGHT HAVE ACTIVATED THE ULTRASONIC OUTPUT CONTACTING TO THE CHANNEL OF THE NEPHROSCOPE AND THE SUBJECT MAJ-984 MIGHT HAVE FRACTURED BY THE FRICTION AT THE CONTACT POINT. THE PHYSICIAN CONTINUED THE PROCEDURE FOR 1 HOUR IN THE ABOVE CONDITION, AND MIGHT HAVE BEEN BURNED FROM THE HIGH TEMPERATURE IRRIGATING FLUID DUE TO THE FRICTION HEAT AT THE CONTACT POINT. ALSO, OLYMPUS STATES THE APPROPRIATE HANDLING OF THE MAJ-984 AND THE COUNTER-MEASURES AGAINST THE IRREGULARITY IN THE INSTRUCTION MANUAL. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. CROSS REFERENCE MFR. REPORT NUMBER 8010047-2017-10038.

D

Patient 1

OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS REPORT IS REQUIRED. OMSC WAS INFORMED OF THE FOLLOWING; A PHYSICIAN PERFORMED A LITHOTRIPSY OF A LARGE STAGHORN STONE WITH A LUS-2, A NON-OLYMPUS NEPHROSCOPE AND THE SUBJECT MAJ-984. AFTER APPROXIMATELY 1 HOUR INTO THE PROCEDURE, THE SUBJECT MAJ-984 FRACTURED IN THE CHANNEL OF THE NEPHROSCOPE. THE PHYSICIAN WITHDREW THE NEPHROSCOPE AND THE SUBJECT DEVICE WAS RETRIEVED. THE SUBJECT MAJ-984 DID NOT FALL INTO THE PATIENT AND THERE WAS NO PATIENT INJURY. THE PHYSICIAN'S HAND WAS BURNT WHEN IT CONTACTED THE IRRIGATING FLUID WHICH WAS VERY HOT. THE PHYSICIAN COMPLETED THE PROCEDURE USING ANOTHER MAJ-984. THIS MDR IS TO ACCOUNT FOR THE BURN ON THE PHYSICIAN.