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

Model Number GIF-XQ260

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacture history of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during a gastroscopy, the angulation wire snapped whilst the bending section of the subject device was angulated in the retroflexed position within the patient¿s stomach.The bending section could not be straightened prior to removal and had to be removed from the patient in the retroflexed position.It was reported that the patient felt uncomfortable on the removal, but there was no injury.The procedure was completed by using another device (ct scan).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) but omsc reviewed the design history file (dhf) of the subject device.Considering the reported event situation and the specification of the angulation, it is surmised that the user facility angulated the bending section in "up" direction for retroflexed position.In the dhf review, the bending section could be angulated ¿down¿ direction, even if the ¿up¿ direction angulation wire is snapped.However, omsc can not determine the cause of the reported event.If additional information is received, this report will be supplemented.

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: 8114436
• MDR Text Key: 129308695
• Report Number: 8010047-2018-02321
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XQ260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 12/26/2018; 02/13/2019
• Supplement Dates FDA Received: 01/24/2019; 02/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1