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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEM CORPORATION EVIS EXERA DUODENOVIDEOSCOPE DUODENOSCOPE Back to Search Results
Model Number TJF-160F
Device Problems Contamination (1120); Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Date 07/15/2015
Event Type  Death  
Manufacturer Narrative
The device referenced in this report has not yet been returned to olympus for evaluation. An olympus endoscopy support specialist (ess) visited the facility on 08/27/15 and performed a demonstration of olympus reprocessing instructions. It was observed that the customer uses a non-olympus leak tester, non-olympus automated flushing unit, and a non-olympus automated endoscope reprocessor to reprocess their scopes. A review of the instrument history shows that the device, serial number (b)(4) was last serviced on november 4, 2004 and serial number (b)(4) was last serviced on june 22, 2011. In addition, on september 3, 2015, the user facility informed olympus that they use a non-olympus leak tester and do not utilize olympus for servicing their tjf-160f device. The exact cause of the patient's outcome could not be conclusively determined at this time. If additional information becomes available at a later time, this report will be supplemented. Please cross reference mfr numbers 2951238-2015-00427 and 2951238-2015-00428.
 
Event Description
On august 19, 2015 olympus became aware via a news article that the facility has reported three patient infections to health officials. Olympus received a medwatch form on august 24, 2015 stating that, "as reported to (b)(6) public health on (b)(6) 2015 by (b)(6), rn, bsn, phn, cphq, cic, infection control preventionist, three patients were admitted with septicemia following an endoscopic retrograde cholangiopancreatogram (ercp) procedures. The patients were positive for similar multi-drug resistant pseudomonas. " olympus followed up with the user facility on september 1, 2015 to obtain additional information regarding the reported event and was informed that the three patients expired after the procedure. It is unknown which of the duodenoscopes (serial #'s (b)(4)) was used on the three patients. The facility stated that the health authorities will determine the cause of death. The scope has been cultured by the facility but test results were not provided. It is unknown at this time what led to the patients outcome. No additional information was provided at this time. This is one of three reports.
 
Manufacturer Narrative
This supplemental report is being submitted to report additional information and to cross reference the additional mfr. Report numbers. Olympus received an article on june 02, 2016 entitled "11deaths at (b)(6) hospital among patients infected by dirty scopes" and a copy of the (b)(6), which claims that a retrospective investigation had been conducted at the facility that included identification of up to 35 cases of possible mdr pseudomonas aeruginosa; however, only 16 patient infections were confirmed and 11 of those patients have expired. The report alleges that all of the patients had undergone endoscopic retrograde cholangiopancreatography (ercp) procedures between january 2013 and august 2015 with one or more of the duodenoscopes (two tjf-160f and onetjf-q180v) that were reportedly linked to the outbreak. It was reported that in march 2016, the user facility notified (b)(6) of new positive mdr pseudomonas aeruginosa blood and urine cultures isolated from a patient who had undergone an ercp procedure in july 2013 with one of the tjf-160f duodenoscopes linked to the prior 15 case patients. The investigation reported that on july 14, 2015 one of the duodenoscopes (tjf-160) was taken out of service and on august 19, 2015 at the recommendation of (b)(6), the second duodenoscope was also removed from service. As of may 18, 2016 death certificates were registered in (b)(6) for 11 patient however only one of the certificates list the cause as "pseudomonas bacteremia. " the report states that the facility had five duodenoscopes; three were owned (two tjf-160f, one tjf-q 180v), and two were loaners (tjf-160f). The facility utilizes three automated endoscope reprocessors (aers) which are manufactured by medivators (model: dsd-201). The report indicated that all three owned duodenoscopes tested positive for pseudomonas aeruginosa which matched patient cultures. It is unknown whether the account either cultured or recovered microorganisms form the loaned duodenoscopes. As part of the phhd investigation an onsite visit was conducted on august 20, 2015. The public health team observed visible residue in an aer basin. These findings did not implicate a source for pseudomonas aeruginosa, but did indicate a need for general improvement in environmental conditions and aer maintenance. (b)(6) recommended that the user facility implement all corrective actions provided by cdph l&c and cms including improving duodenoscope storage conditions and correction of reprocessing procedures that did not follow nationally recognized standards. (b)(6) recommended that the user facility update policies and procedures for maintenance, storage, and surveillance cultures according to the most current cdc and manufacturer (olympus) guidelines. The user facility implemented a plan for surveillance monitoring for new cases. (b)(6) also recommended thorough servicing of aers, and replacement of all replaceable parts in the aers, including tanks. On september 11, 2015 the public health team returned to the site and confirmed that the user facility was reprocessing every duodenoscope twice. The facility had implemented improvements to duodenoscope reprocessing and storage. The reports state that the user facility was provided current recommendations from olympus to return all tjf-q180v duodenoscopes for elevator mechanism replacement and new reprocessing instructions. The report stated that no additional cases were identified via weekly prospective surveillance from august 20, 2015 to december 11, 2015, or via patient notification and testing. Based on this new information olympus submitted 15 initial mdrs to separately account for the remaining 16 patients and positive device cultures. A review of complaint database history revealed olympus previously submitted four initial mdrs between september 8, 2015 and february 2, 2016 to account for three reported deaths and one reported patient infection. Please cross reference the remaining mfr. Report numbers:2951238-2015-00426, 2951238-2015-00427, 2951238-2015-00428, 2951238 - 2016 - 00382, 2951238 - 2016 - 00383, 2951238 - 2016 - 00384, 2951238 - 2016 - 00385, 2951238 -2016-00546, 2951238 -2016-00547, 2951238 - 2016 - 00548, 2951238 - 2016 - 00549, 2951238 - 2016- 00550, 2951238 - 2016- 00551, 2951238 -2016- 00552, 2951238 - 2016- 00553, 2951238 - 2016- 00554, 2951238 - 2016- 00555, 2951238 -2016- 00556, 2951238 -2016- 00557, 2951238- 2016- 00558, 2951238 - 2016 -00559 and 2951238 - 2016 - 00560.
 
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Brand NameEVIS EXERA DUODENOVIDEOSCOPE
Type of DeviceDUODENOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho,
hachioji-shi, tokyo,, 192-8 507
JA 192-8507
Manufacturer Contact
noemi schambach
2400 ringwood avenue
san jose, CA 95131
4089355002
MDR Report Key5062220
MDR Text Key25208066
Report Number2951238-2015-00426
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 06/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTJF-160F
Device Catalogue NumberTJF-160F
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 Received06/02/2016
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: 09/08/2015 Patient Sequence Number: 1
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