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

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.

• 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 Key: 3608977
• MDR Text Key: 16687134
• Report Number: 2951238-2014-00027
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: TJF-Q180V
• Device Catalogue Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• 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 Treatment Data

Date Received: 01/28/2014 Patient Sequence Number: 1

Treatment

MEDIVATORS SCOPE WASHER MODEL/SN# UNK; SCOPE BUDDY MODEL/SN# UNK; MEDIVATORS SCOPE WASHER MODEL/SN# UNK; SCOPE BUDDY MODEL/SN# UNK