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

Model Number GIF-XP260NS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to omsc.But was returned to olympus (b)(4) for evaluation.In the evaluation, (b)(4) found no abnormality in the subject device.It was also confirmed that there were no defects ascribable to the cause of the reported event such as breakage of the lens on the distal end and sharp edge of the air/water nozzle.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 patient suffered an esophageal laceration near the larynx during an unspecified procedure using the subject device.The intended procedure was completed using the subject device.The outcome of the patient is unknown.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• 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
• MDR Report Key: 7654156
• MDR Text Key: 112840957
• Report Number: 8010047-2018-01263
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-XP260NS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other