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

Model Number GIF-2TH180

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

The scope and the biopsy cap were returned to olympus for evaluation.The evaluation confirmed the reported event.A visual inspection found the rubber cap damaged.In addition, the scope¿s biopsy channel was found leaking.There was a tear mark found inside the biopsy channel wall that likely contributed to the leak.The light guide lens was also found cracked.The scope was serviced and returned to the user facility.Based on the evaluation findings, the cause of the damaged biopsy cap is likely due to user handling / excessive force when inserting an accessory instrument through the biopsy cap.The instruction manual for use provides warning statements in an effort to prevent damage to the biopsy cap.¿slowly insert or withdraw the endotherapy accessory straight into or from the slit of the biopsy valve.Otherwise, the biopsy valve may be damaged and pieces of it could fall off.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and could cause some parts to fall off and/or cause patient injury.¿.

Event Description

Olympus was informed that towards the end of an upper endoscopy procedure, a small device fragment (biopsy cap) was found inside the patient¿s stomach.The device fragment was retrieved from the patient.The procedure was completed using the same scope.No patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fdf 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: 6762183
• MDR Text Key: 81809860
• Report Number: 2951238-2017-00507
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-2TH180
• Device Catalogue Number: GIF-2TH180
• Device Lot Number: N/A
• Other Device ID Number: 04953170339752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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