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 Problems Burning Sensation (2146); Electric Shock (2554)

Event Date 01/16/2014

Event Type  Injury  

Event Description

Olympus was informed that during an esophageal dilation procedure, one of the nurses felt a shock and a burning sensation on the tip of her finger while holding the scope.A visible white circle was observed on the finger tip of the nurse.The scope was further tested by the biomed and three other nurses and they were all unable to touch the tip with gloves and without gloves due to the burning sensation that was felt.It was also noted that the tip would become hot within 5-20 seconds of turning on the light source device.No patient injury was reported.Additional information received noted that upon further testing by an ess, showed that when the distal end of the scope was covered, while wearing a dark nitrile glove, the larger of two light guides lenses became painfully hot almost instantly but when wearing a light colored glove, the lenses still became hot but the time frame was longer.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The evaluation did not duplicate the user's report of heating at the distal tip of the gastroscope.However, it was found that the distal end cover was cracked at the channel opening, causing the insulation to fail.Deep scratches on the distal end cover were noted as well.The damge on the distal end cover were due to mechanical overload.The biopsy channel was examined with a baroscope and no signs of damages were found inside.The device was serviced 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 WINTER NAD IBE GMBH; kuehnstrabe 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3724162
• MDR Text Key: 4325875
• Report Number: 2951238-2014-00067
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• 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: 02/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other