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

Model Number GIF-HQ190

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject scope was returned to the service center for evaluation.A review of the service history indicates the scope was purchased on (b)(6) 2018 with no repairs related to the reported event.A microscopic inspection of the scope found burn marks on the top and side surfaces of the distal end plastic cover.The likely cause of the burn marks can be from an endotherapy device being activated near the distal end.The distal light guide lens and the objective lens was inspected found with debris internally.The service group noted the distal end plastic cover has deep dents and the bending section cover glue was discolored and cracked; potentially attributed to impact/wear.For testing, the scope was connected to a test video processor (cv-190) and light source (clv-190) with the light brightness settings set to zero on ¿auto brightness¿ mode.The distal tip did not become hot and there was no problem observed.Additional testing was performed, as a calibrated multimeter was used with a thermometer coupler to measure the distal end temperature readings.The temperature of the scope was inspected under manual brightness mode at +4 on the brightness settings and objective lens has a temperature reading of 52.7°c and there was an indication of hot composition when touching the distal end of the scope.The cause of the reported event could not be confirmed as the scope tested normally in auto brightness mode.However, based on the evaluation results, the potential cause can be attributed to the settings on the light source in manual brightness mode with a higher intensity setting in combination with a longer illumination.Per the instruction manual, ¿the temperature of the distal end of the endoscope may exceed 41°c (106°) and reach 50°c (122°f) due to intense endoscopic illumination.Surface temperatures over 41°c (106°f) may cause mucosal burns.Always maintain a suitable distance necessary for adequate viewing while using the minimum level of illumination for the minimum amount of time.Whenever possible, do not leave the endoscope illuminated before and/or after an examination.Continued illumination will cause the distal end of the endoscope to become hot and could cause operator and/or patient burns¿.

Event Description

The service center was informed that during an unspecified procedure, the scope became too hot.No additional information was provided.There was no death or serious injury reported.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9317275
• MDR Text Key: 219773185
• Report Number: 8010047-2019-03955
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2019
• 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