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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE

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OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q180V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 06/14/2013
Event Type  Injury  
Event Description

Olympus was informed that five pts tested positive for carbenepenum resistant enterbacteriaceae containing new delhi metallo-beta-lactamase (cre-ndm) after having undergone an endoscopic retrograde cholangiopancreatography (ercp) procedure. The pts were examined with the same duodenovideoscope. On (b)(6) 2013, the fifth pt underwent an ercp with biliary sphincterotomy and biliary metal stent placement and subsequently developed bile duct and pancreatic duct dilation, and postprandial abdominal pain. The pt was hospitalized for an unspecified amount of time. Since (b)(6) 2013, the pt has been receiving outpatient chemotherapy. On (b)(6) 2013, rectal swab from the pt tested positive for cre-ndm. On (b)(6) 2014, the pt was admitted with intractable nausea and vomiting. An endoscopy support specialist was dispatched to the user facility. A reprocessing in-service has not been scheduled to date.

 
Manufacturer Narrative

The device has not been yet returned for evaluation. The exact cause of the user's experience could not be conclusively determined at this time. A supplemental report will be submitted if additional and significant information becomes available later. Please cross-reference the following reports for the other four pts: 2951238-2014-00023, 2951238-2014-00024, 2951238-2014-00025 and 2951238-2014-00026.

 
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Brand NameOLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE
Type of DeviceDUODENOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192- 8507
JA 192-8507
Manufacturer (Section G)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192- 8507
JA 192-8507
Manufacturer Contact
laura storms
2400 ringwood ave.
san jose, CA 95131
4848965688
MDR Report Key3608977
MDR Text Key16687134
Report Number2951238-2014-00027
Device Sequence Number1
Product Code FDT
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTJF-Q180V
Device Catalogue NumberTJF-Q180V
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/06/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 01/28/2014 Patient Sequence Number: 1
Treatment
MEDIVATORS SCOPE WASHER MODEL/SN# UNK; SCOPE BUDDY MODEL/SN# UNK
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