MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus and it was determined glue residue was present on the distal end of the scope due to insufficient cleaning.

Event Description

A user facility reported to olympus that excessive glue was present at the distal tip behind the elevator.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.Updates to sections h4 and h6.The device history record for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation determined the likely cause of the reported problem is wear, possibly due to an external force during reprocessing or due to the influence of chemicals, used during reprocessing.The instructions for use contains the reprocessing procedures which may prevent the reported phenomenon: 1.) "brushing around the forceps elevator and instrument channel outlet." 2.) "flushing the interior of the forceps elevator.".

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11490165
• MDR Text Key: 245038340
• Report Number: 8010047-2021-03729
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1