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

Model Number GIF-H180J

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2014

Event Type  Other  

Event Description

Olympus was informed that the device did not pass multiple bacteria tests.It was stated that there were constant high readings of unspecified bacteria after sterilization.There was no pt infection or injury reported.Olympus followed up with the user facility in an effort to obtain additional info regarding the reported event, but with no results.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation and was sent to an off-site independent lab for microbiological testing.Based on the lab results there were multiple cocci bacteria and mold recovered from the device.The device was returned to olympus for physical evaluation.The instrument channels of the device were examined with a boroscope, and a slight residue and debris were noted inside the instrument channel, suction cylinder, auxiliary water channel and other internal components of the device.There were also scrapes and tears noted in the instrument channel near the bending section area.The device was refurbished and returned to the user facility.The exact cause of the reported event could not be conclusively determined, but insufficient reprocessing cannot be ruled out as a contributory factor.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP; 2951 ishikawa-cho; hachioji-shi 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS 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: 3851026
• MDR Text Key: 4412088
• Report Number: 2951238-2014-00230
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180J
• Device Catalogue Number: GIF-H180J
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2014
• 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