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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q180V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Blood Loss (2597)
Event Date 11/10/2014
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation or service at this time. An olympus endoscopy support specialist (ess) visited the site to assess the reprocessing practices at the user facility and provided training and education to the user facility staff on the following dates: january 30, 2015, january 31, 2015 and february 03, 2015. The ess noted reprocessing inconsistencies during the site visit. Olympus followed up with user facility to obtain additional information regarding the reported event by telephone and in writing but with no results.
 
Event Description
Olympus received (b)(4) which reports that a patient became infected with (b)(6) after undergoing an endoscopic retrograde cholangiopancreatography (ercp) and esophagogastroduodenoscopy (edg) procedure using a duodenvideoscope. It was reported that six days after the procedure the patient presented to the emergency room and was admitted to the hospital with hematemesis, epigastric pain radiating through the right upper quadrant. The patient was found to have a gi bleed. The patient underwent a blood transfusion and was administered fresh frozen plasma (ffp). On day two of admission the patient began to display signs of fever and was transferred to the medical intensive care unit (micu) and started on bipap. The patient's intravenous antibiotic was changed from zosyn to meropenem. The patient continued to exhibit high fevers associated with rigoring and was intraoperatively found to have a puss filled necrotic gallbladder. A subtotal cholecystectomy was performed with a mallinkodt drain within the gallbladder infundibulum. The pancreatic drain was replaced, with a pancreatic debridement. It was determined that by hospital day 40 the patient was no longer actively infected but was colonized with (b)(6). The patient was discharged to a skilled nursing facility in stable condition. In the same medwatch report the user facility reported that after an epidemiologic and microbiologic investigation conducted by the user facility on all of the cre patients; the user facility reported a cluster of patients were identified with klebsiela pneumonia. The user facility reported that all eight of the patients had undergone ercp procedures with a duodenvideoscope approximately within a three month period.
 
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Brand NameEVIS EXERA II DUODENOVIDEOSCOPE
Type of DeviceDUODENOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
donny shapiro
2400 ringwood avenue
san jose, CA 95131
408935-516
MDR Report Key5729389
MDR Text Key47529327
Report Number2951238-2016-00501
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK143153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTJF-Q180V
Device Catalogue NumberTJF-Q180V
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/16/2016 Patient Sequence Number: 1
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