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

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.

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOSCOPE
• 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 Key: 5062220
• MDR Text Key: 25208066
• Report Number: 2951238-2015-00426
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-160F
• Device Catalogue Number: TJF-160F
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR