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 returned to an olympus service center for evaluation and the issue was confirmed.The insertion tube was sticky and there was a foreign black residue found in the forceps passage.In addition, the cover glue was peeling and there was a crack in the glue.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported to olympus there was glue stuck on the insertion tube and inside the evis exera ii ultrasound gastrovideoscope.The issue was found at reprocessing.No patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.Judging from the manufacturing year of the subject device, it was unlikely that the peeling was due to aging deterioration.It was likely that the phenomenon occurred because external force was applied to the relevant part by strongly rubbing it during daily use including reprocessing.The instructions for use (ifu) provides the following guidelines: inspection of the endoscope 3.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, forming objects, or other irregularities.

• 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: 11965124
• MDR Text Key: 255120768
• Report Number: 8010047-2021-07286
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341809
• UDI-Public: 04953170341809
• 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: 07/26/2021

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: 05/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 07/05/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1