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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS DUODENOVIDEOSCOPE

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OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS DUODENOVIDEOSCOPE Back to Search Results
Device Problem No Known Device Problem
Event Date 01/01/2013
Event Type  Death  
Manufacturer Narrative

No devices were returned to olympus for evaluation. Olympus offered an on-site visit to the user facility to assess their reprocessing practices, but the user facility declined. The exact cause of the pt outcome could not be conclusively determined. If additional and significant info becomes available at a later time, this report will be supplemented. Cross reference mfr report numbers: 2951238-2014-00347, 00348, 00350, 00351, 00352, 00353, 00354, 00355, 00356, 00357, 00358, 00359, 00360, 00361, 00362, 00363, 00364, 00365, 00366, 00367, 00368, 00369, 00370, 00371, 00372, 00373, 00374, 00375, 00376, 00377, 00378, 00379, 00380, 00381, 00382, and 00383.

 
Manufacturer Narrative

Olympus followed up with the user facility multiple times via telephone and in writing to obtain additional info regarding the reported events, but was unsuccessful. The initial follow-up was made on july 28, 2014, via telephone and in writing. Subsequent follow-ups were made on the following dates: july 29, 2014 via electronic mail, july 30, 2014, august 7, 2014 via a teleconference call with attendees from the user facility and olympus, august 12, 2014, august 14, 2014, august 20, 21, 22, 2014. On august 27, 2014, the user facility declined the on-site visit that olympus offered in an attempt to collaborate on a physical inspection of all the duodenoscopes involved in the reported events. Olympus performed an inventory search for devices sold to the user facility based on the news article dated january 21, 2015 and determined the user facility had five (5) tjf-160vf and 23 tjf-q180v. Based on the higher probability that a 180 model was used on the reported events, olympus supplemented the 37 mdrs changing the duodenoscope model from tjf-160vf to tjf-q180v. However, the specific model of duodenoscopes used during the reported events still remains unk, as the user facility has not responded to olympus' inquiries.

 
Event Description

Olympus was informed of 37 alleged infections at the user facility involving multiple duodenoscopes (160 series/180 series). In early 2013 the washington state department of health identified seven cases of carbapenem resistant enterobacteriaceae (cre) cultures from samples sent by the user facility. There were no specific endoscope models or serial numbers provided by the user facility. Four deaths were identified by the user facility. The cause of patient death is unk. Additionally, olympus was notified of 30 pt infections based on culture of variant e. Coli from patient's blood, bile, urine, or the respiratory tract. Olympus contacted the user facility via telephone and in writing to obtain more detailed info regarding the reported events but no further info was provided.

 
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Brand NameOLYMPUS DUODENOVIDEOSCOPE
Type of DeviceDUODENOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho, hachioji-shi
tokyo 192- 8507
JAPAN 192-8507
Manufacturer (Section G)
OLYMPUS MEDICAL SYSTEM CORPORATION
Manufacturer Contact
noemi schambach
2400 ringwood ave.
san jose , CA 95131
4089355002
MDR Report Key4077780
Report Number2951238-2014-00349
Device Sequence Number1
Product CodeFDT
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2014
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: 08/22/2014 Patient Sequence Number: 1
Treatment
TFJ-Q18V, SERIAL NUMBER (UNKNOWN)
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