MAUDE MDR 6943324

MDR report key
6943324
Report number
8010047-2017-99130
Event key
0
Event type
3
Date received
2017-10-12
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. KATSUAKI MORITA
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8 JA
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ENDOSCOPIC CO7 REGULATION UNITCO2 REGULATION UNITOLYMPUS MEDICAL SYSTEMS CORP.FCXUCRR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-1201. O; 2. S

Event Narratives#

N

Patient 1

THE REFERENCED UCR WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION. HOWEVER THE TECHNICIAN OF THE OLYMPUS (B)(4) EVALUATED THE UCR AND FOUND THAT, THOUGH THE UCR HAD THE DAMAGE AND DISCOLORATION WHICH WERE UNRELATED TO THE FUNCTION, THE UCR OPERATED WITHOUT PROBLEM AND THE FUNCTION OF THE INSUFFLATION WAS CORRECT. THE EXACT CAUSE OF THE REPORTED PHENOMENON CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, ACCORDING TO THE LITERATURE, IT IS KNOWN THAT ABDOMINAL PAIN IS COMMON COMPLICATION AFTER COLONOSCOPY DUE TO RESIDUAL AIR IN INTESTINAL TRACT. THE AIR IS EMITTED, AND THEN THE ABDOMINAL PAIN WILL BE RESOLVED. THEREFORE OMSC CONCLUDED THAT THIS PHENOMENON WAS ATTRIBUTED TO COMMON COMPLICATION OF COLONOSCOPY. OLYMPUS STATED THE APPROPRIATE HANDLING OF THE UCR IN THE INSTRUCTION MANUAL. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

D

Patient 1

AFTER THE COLONOSCOPY, THE PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN. OTHER PATIENT'S INJURY AND ANY MEDICAL INTERVENTION WERE NOT REPORTED.

N

Patient 1

THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2017-99130 TO CORRECT SECTION. AS PREVIOUSLY REPORTED, BOTH "DISABILITY OR PERMANENT DAMAGE" AND "OTHER SERIOUS (IMPORTANT MEDICAL EVENTS)" WERE CHECKED. HOWEVER IT WAS CORRECT THAT "OTHER SERIOUS (IMPORTANT MEDICAL EVENTS)" ONLY WAS CHECKED.