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

Model Number TJF-Q180V

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 02/13/2013

Event Type  Injury  

Event Description

The subject device was returned to olympus (b)(4) for repair purpose. (b)(4) sterilized and repaired the subject device as routine work. After that, (b)(4) rec'd the info that some pts which were treated with the subject device got a klebsiella infection. According to info from the facility, the same bacteria was not detected from the subject device. There were no add'l info.

Manufacturer Narrative

Since the subject device had already sterilized and repaired, olympus med sys corp. (omsc) could not evaluate it. Thus, omsc cannot conclusively determine the cause of this event. However, it can be considered as a possible cause of this phenomenon that pts infected from other than the endoscope and procedure such as environmental factor in the facility, because the same bacteria was not detected from the subject device. This report is being submitted as a medical device report in an abundance of caution.

Manufacturer Narrative

This supplemental report is being submitted upon further review of the mdr complaint filed on (b)(6) 2013. It has been determined that 4 additional mdrs are needed to account for the reported number of patients allegedly infected by the scope. Please cross reference these associated complaints: 8010047-2015-00212, 00213, 00214, and 00215.

Event Description

This supplemental report is being submitted to provide additional information based on the medical journal article that olympus found on (b)(6) 2015. Between (b)(6) 2012 and (b)(6) 2013, carbapenem-resistant klebsiella pneumonia (crkp) was cultured from 12 patients who stayed on 4 different clinical wards. The 5 out of 12 patients were tested positive for crkp after undergoing an endoscopic retrograde cholangiopancreatography (ercp) with the subject device. The user facility cultured the subject device, and no crkp was detected. The first patient underwent the ercp on (b)(6) 2013 with the device, and subsequently crkp was detected from patient's blood culture on (b)(6) 2013. The patient had septicemia. Information on the patient outcome was not provided.

Manufacturer Narrative

According to the request from the olympus (b)(4) disassembled the subject device in conjunction with personnels from the user facility. They took eight samples from each part dismantled from the subject device for culture test. The personnels from the user facility brought them back and performed the culture test. Subsequently, all samples collected from the parts were tested negative. Based on the result of the culture test, olympus medical systems corp. , thinks that this event was most likely caused due to the other cause than the subject device.

Event Description

This is a supplemental report for mfr report # 8010047-2013-00092 to provide additional information based on the report from the user facility through bfarm, competent authority in (b)(4). A patient who had been diagnosed with klebsiella pneumonia was examined on (b)(6) 2013. In total, the subject device was used to carry out another twenty-eight examination on twenty-six patients between (b)(6) before it was sent to olympus for repair. Subsequently, k. Pneumonia were found 5 of these patients. Two of the five patients have since died. Olympus medical systems corp. , has not been informed the cause of the patient death.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DOUDENOVIDEOSOCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi 19285 07; JA 1928507
• Manufacturer Contact: hiroki moriyama
• MDR Report Key: 3095661
• MDR Text Key: 19420118
• Report Number: 8010047-2013-00092
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/28/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data

Patient Treatment Data

Date Received: 04/25/2013 Patient Sequence Number: 1