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

Model Number GIF-H190

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The scope has not been returned to olympus for evaluation; however, olympus performed an instrument service history review in an attempt to gather additional information on the reported scope.The scope was last returned for service on december 12, 2016 for an unrelated leak issue.The cause of the reported parasite could not be determined at this time.As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained.In addition, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.Olympus will continue to investigate this report and submit a supplemental report if additional information is received.

Event Description

Olympus was informed that after an upper endoscopy procedure, the patient was diagnosed with the giardia parasite.It is unknown if the scope caused or contributed to the patient¿s outcome.The user facility uses a non-olympus automated endoscope reprocessor (aer) machine.The reported scope has not been used since the reported event occurred.

Manufacturer Narrative

On september 28, 2017, the olympus endoscopy support specialist (ess) contacted the user facility to offer an in-service reprocessing observation and training.The user facility stated that their reprocessing questions have been resolved following the olympus instruction manual for use.It was also reported that the scope has been reprocessed with no further issues.The user facility declined the ess in-service.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fdf to fds and 510(k) number.

• Brand Name: EVIS EXERA III 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: 6901694
• MDR Text Key: 87666972
• Report Number: 2951238-2017-00648
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Device Catalogue Number: GIF-H190
• Device Lot Number: N/A
• Other Device ID Number: 04953170305290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• 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
• Treatment: MEDIVATORS AER, SN# UNKNOWN; RAPICIDE, LOT# UNKNOWN
• Patient Outcome(s): Other