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

Model Number GIF-HQ190

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported positive culture scope; however, the user facility provided limited information.The scope was returned to olympus for evaluation; however, the evaluation is still pending results.The scope will be sent to an independent laboratory for microbial testing and ethylene oxide (eto) sterilization.As part of our investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.

Event Description

Olympus was informed that after reprocessing, the scope culture tested (b)(6) for (b)(6).There was no patient involvement with the reported scope.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fdf to fds and 510(k) number.

Manufacturer Narrative

This supplemental report is being submitted to provide the olympus endoscopy support specialist (ess) on-site findings, the independent laboratory results, and the device evaluation findings.The ess visited the user facility on september 8, 2017 to observe the facility¿s reprocessing practice and to provide a reprocessing training.The ess found no reprocessing deviations; however, the ess did note that the user facility utilizes a non-olympus cleaning brush.The scope was sent to an independent laboratory for microbial testing.The scope tested positive for micrococcus luteus, staphylococcus epidermidis, and paenibacillus glucanolyticus.The scope was then ethylene oxide (eto) sterilized and returned to olympus for a device evaluation.Olympus performed a visual inspection on the scope and was unable to find any signs of foreign material inside the biopsy channel, biopsy port, suction channel, suction port, air/water port, nozzle, insertion tube, bending section cover, bending section cover glue, distal end cover, light guide lens, and objective len when inspected with an olympus borescope and telescope test equipment.The bending section cover glue was found with a gap and slight discoloration.A leak was also noted on the biopsy channel from the distal end side of the scope.The biopsy channel was inspected with a borescope and found torn marks inside the biopsy channel wall at the distal end side; which likely caused the leak.The scope was serviced and returned to the user facility.Based on the independent laboratory results and investigation findings, improper maintenance could not be ruled out as a contributor factor to the reported positive culture.The instruction manual for use states, ¿the probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase.In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically following regulations, guidelines, etc.Required of you.An endoscope with an observed irregularity should not be used, but should be inspected by following section 5.2, ¿troubleshooting guide¿.If the irregularity is still observed after inspection, contact olympus.¿ the reprocessing manual also states, ¿perform a leakage test on the endoscope after each pre-cleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.¿.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6850176
• MDR Text Key: 86842857
• Report Number: 2951238-2017-00595
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Device Catalogue Number: GIF-HQ190
• Device Lot Number: N/A
• Other Device ID Number: 04953170305276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• 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