MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA LLL COLONOVIDEOSCOPE

Model Number PCF-H190L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus for evaluation. A review of the instrument¿s history was performed and found that the device had not been returned for service/ repair since the date of purchase on (b)(6) 2015. The cause of the reported event cannot be determined at this time. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event. If additional information becomes available, this report will be updated and supplemented accordingly.

Event Description

Olympus was informed that two patients developed a carbapenem-resistant enterobacteriaceae (cre) infection after undergoing unspecified procedures using the colonovideoscope in (b)(6) 2018 and (b)(6) 2018. The patient¿s course of treatment is unknown. In addition, the user facility reported that the colonovideoscope was sent to a third party for culturing and tested negative for growth. This is report 2 of 2.

• Brand Name: EVIS EXERA LLL COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8143728
• MDR Text Key: 129754438
• Report Number: 2951238-2018-00748
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCF-H190L
• Device Catalogue Number: PCF-H190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/22/2019
• 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: 12/07/2018 Patient Sequence Number: 1