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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.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the investigation of the device.As part of our investigation into this report the device was sent to an independent off-site laboratory for microbiological testing and escherichia coli was recovered from the device.The device was then forwarded to olympus for physical evaluation.The device was returned to olympus for evaluation.The device passed the leak test.The evaluation found no issues that could contribute or confirm the reported phenomenon.There was no sign of bio-materials in the device.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on further review of the complaint record.On (b)(4) 2014 the olympus endoscopy support specialist (ess) visited the user facility to observe the facilities reprocessing practices and to provide additional reprocessing training.The following observations were noted during the visit: the user facility was using a non- olympus cleaning brushes, which are short and narrow.There was no suction pump and suction cleaning adapter in the reprocessing room, and the scopes were not being hang freely as instructed in the reprocessing manual.The reprocessing manual clearly states that a suction pump is needed during the manual cleaning process (see tjf-q180v reprocessing manual, pages 65-66).The suction pump is required to allow the user to aspirate the detergent solution through the tjf-q180v's instrument channel and suction channel.
 
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Brand Name
OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE
Type of Device
DUODENOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA  192-8507
Manufacturer (Section G)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192-8 507
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 08/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/06/2014
Initial Date FDA Received01/28/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
MEDIVATORS SCOPE WASHER MODEL/SN# UNK; SCOPE BUDDY MODEL/SN# UNK; MEDIVATORS SCOPE WASHER MODEL/SN# UNK; SCOPE BUDDY MODEL/SN# UNK
Patient Outcome(s) Hospitalization; Other;
Patient Age74 YR
Patient SexFemale
Patient Weight56 KG
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