MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H180

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Olympus cannot determine if the gastroscope referenced in the article has been returned to olympus for evaluation or not, as there was no specific serial number of gastroscope was provided in the article.The cause of the reported incidents cannot be determined at this time, but improper maintenance of the device cannot be ruled out as a contributory factor to the reported events.Olympus will continue to investigate this report and will update the report if additional information becomes available at a later time.

Event Description

On november 1, 2016 olympus received a clinical article titled, ¿carbapenem-resistant klebsiella pneumoniae (cr-kp) cluster associated with gastroscope exposure among surgical intensive care unit (sicu) patients upmc.The article showed that in (b)(6) 2016 an increase in cr-kp isolates was observed in the open 8 bed sicu at the facility.A total of six cases were identified in (b)(6) and all six cases were exposed to the same or gastroscope.As a result, the facility conducted an investigation to determine the exposure source as well as the relatedness of cr-kp strains.The user facility collected rectal swabs on all current in-patients exposed to the sicu in (b)(6) 2016 to assess for cre carriage.Aside from the six cases, no patients exposed to the gastroscopes were still in patient at the time of the investigation.The gastroscope was removed from service and reprocessing records were reviewed.The facility conducted a microbiologic assessment utilizing two scope culture techniques.A boroscopy was performed to examine the scope lumen for defects.The facility staff moved patients out of the sicu to thoroughly clean space and conduct ultraviolet light disinfection.The cr-kp isolates were sent to microbial genome epidemiology laboratory (migel) for pulsed-field gel electrophoresis (pfge) typing and whole genome sequencing (wgs) to assess relatedness.Forty-three (43) additional patients were reportedly exposed to sicu in january, and 19 out of the 43 were still in house and available for rectal screening.Only 17 out of 19 patients had undergone rectal swabbing, as two patients were discharged prior to obtain the swab.One of the patient¿s rectal swab tested positive for cr-kp but this patient was never exposed to the gastroscope.As a result of the positive rectal swab, the facility continued the weekly screening until no new positive results, and subsequent testing were negative for cre; therefore, the weekly screening was stopped.The article showed that based on the assessment conducted on the gastroscope the following information were reported: no deficiencies identified with scope reprocessing, no organisms identified using either of the scope culturing methods, boroscopy of the scope lumen revealed deep scratches and luminal debris, after boroscopy the scope lumen was removed and replaced with new lumen before returning to service.The gastroscope was reportedly used on a patient with a known cr-kp at the end of (b)(6) 2015.The article showed that a cr-kp transmission likely occurred through a contaminated gastroscope.6 of 6 reports.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from gck to fds.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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 ; 408935-512
• MDR Report Key: 6137216
• MDR Text Key: 61193338
• Report Number: 2951238-2016-00905
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2019

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: GIF-H180
• Device Catalogue Number: GIF-H180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/03/2019
• 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): Other