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

Model Number GIF-H180

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the service center for evaluation.The service group confirmed there was a foreign object inside the instrument channel of the scope.In addition, the distal bending section cover glues were cracked and deep dents on the distal end cover.The instrument channel wall was scraped.A review of the service history indicated the scope was purchased on (b)(6) 2012 with three repairs in the past three years; no repairs involving foreign objects lodged inside the channel of the scope.The scope was repaired and returned to the user facility.As part of the 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.The cause of the reported event could not be determined.However, chapter 3 of the instruction manual states, before each case, to prepare and inspect the scope as instructed.When inspecting the instrument channel, the instruction manual states, to ¿insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end.Also make sure that no foreign objects come out of the distal end.¿.

Event Description

The manufacturer was informed that during an unspecified procedure, part of a channel cleaning brush fell into the patient's stomach.The user facility reported that while reprocessing the scope, the cleaning technician was using a third party channel cleaning brush.While cleaning, the brush broke and a piece of the brush became lodged inside the scope's instrument channel.It was believed the brush fragment came out of the scope during cleaning.Subsequently, the scope was used on a patient and when the doctor inserted forceps into the instrument channel the brush fragment became dislodged out of the distal end of the scope and into the stomach of the patient.The facility believes the brush fragment was retrieved from the patient, however, the broken brush fragment did not come out the other end of the scope and the facility assumed that the brush fragment remained inside the scope.The facility will be sending the patient to x-ray to verify that it is not inside the stomach or the patient.There was no patient injury reported.

Manufacturer Narrative

The endoscopy support specialist (ess) visited the user facility to observe the user facility reprocessing practice and to provide training.The reviewed the facility's reprocessing and handling process with the staff and found the staff was not using air/water adapters consistently during pre-cleaning and are using us endoscopy channel brushes during manual cleaning.The staff was not using suctioning during manual cleaning and the facility utilizes a medivators automated endoscope reprocessor (aer) machine.The ess conducted a reprocessing in-service and reviewed proper reprocessing with facility and staff.The ess recommended the staff start using proper air/water cleaning adapter in pre-cleaning portion as well as incorporate the proper suction steps during manual cleaning.The ess promoted use of olympus brushes and olympus aer-pro.The ess emailed a copy of the attendance and in-service ontrack form and left reprocessing wall chart with the staff.Additionally, the ess covered infection control information referenced in the instructions for use.

• Brand Name: EVIS EXERA II 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: 9375431
• MDR Text Key: 206776095
• Report Number: 8010047-2019-04084
• Device Sequence Number: 1
• Product Code: FDS
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/10/2020
• 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