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

Model Number GIF-Q260

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

There are no informations on the patients outcome, the frequency of the reported events, and so forth.Omsc will visit to the facility to check the subject device.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that a physician sometimes experienced that micro-bleeding from the gastric mucosa occurred after retroflexed observation in the stomach during unspecified procedures.The user facility commented that the reported events had occurred after a repair conducted on (b)(6) 2017.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information and the device investigation result.Olympus medical systems corp.(omsc) visited the user facility to confirm the subject device.Omsc inspected the external appearance of the subject device and there were no such malfunctions found on the subject device as leading to bleeding.In addition, omsc informed the user facility about the inspection result and the user facility said that ¿there may be some problems with insertion technique.¿ the user facility decided to continue use of the subject device, therefore, the subject device was not returned to omsc.Based on the investigation result of the subject device and user's comment, user's handling of the subject device cannot be ruled out as a possible cause of the event.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7044299
• MDR Text Key: 92474109
• Report Number: 8010047-2017-01825
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-Q260
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2005
• 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