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

Model Number GIF-H180J

Device Problems Device Contamination with Body Fluid (2317); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

As reported for this event by the customer, pre-cleaning and manual cleaning of the device was not performed immediately after the procedure.The device was kept all night with the dried crusted blood inside.The device was then reprocessed in the morning and sent in for evaluation and repair without being used any further in any procedure.There is no patient involvement.

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection and testing, there was no trace of blood found inside the device biopsy channel when checked with a borescope.Other observations for the device are: distal end rubber coating (a-rubber) has leaks on insertion side; a-rubber glue has cracks; distal end plastic cover has dents; forceps passage has scrapes and tear marks; switch 1 has cuts; angulation is low; and there is a customer label on the s-connector.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Manufacturer Narrative

Customer confirmed the device was not used for a procedure.This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 14202506
• MDR Text Key: 299177024
• Report Number: 8010047-2022-07015
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339110
• UDI-Public: 04953170339110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2022
• 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