MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORP EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE; GASTROSCOPE

Model Number GIF-H180

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 02/01/2014

Event Type  Injury  

Event Description

Olympus was informed that during an esophageal dilation procedure, one of the nurse burnt her hand while holding the scope.The issue was investigated by an olympus representative who stated that when the distal end of the scope was covered, while wearing dark nitrile gloves, the larger of the two light guide lenses became painfully hot almost instantly, but when wearing lighter colored gloves, the lenses still became hot but took considerably longer.No patient injury has been reported.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The evaluation confirmed the user's report of heating at the distal tip of the gastroscope.This is not a defect or known problem of the endoscope, rather it is a normal function.The endoscope was evaluated using olympus test equipment for an extended period of time.In order to duplicate the reported phenomenon of a hot distal tip, a test protocol was set up where the light guide lens and objective lens were completely covered with dark nitrile gloves.After covering the light guide lens and objective lens with a purple (dark) glove, the temperature of the light guide lens exceeded 94 degrees.A brighter light guide lens and higher temperature could be felt from the lens within 3 seconds.In order to prevent a distal tip from heating up, regulatory affairs urge the customer to follow the ifu warning regarding temperature of the distal end of the endoscope (chapter 4).The device was refurbished and returned to the user facility.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP; 2951 ishikawa-cho, hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEM CORP; 2951 ishikawa-cho, hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3677296
• MDR Text Key: 17843467
• Report Number: 2951238-2014-00084
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180
• Device Catalogue Number: GIF-H180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2014
• 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
• Patient Outcome(s): Other