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

Model Number GF-UCT180

Device Problems Poor Quality Image (1408); Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been evaluated by olympus.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the c-body brush is stuck in the c-body and the pink coding glue is open.The biopsy channel is damaged.There is shadow in the echo signal and one element broken.Angulation was low.The endoscope has been reassembled with a new insertion tube unit.This includes all internal insertion tube components: ccd with objective lenses, four angulation wires, light guide bundle with lenses, air/ water channel, and biopsy (suction) channel.The endoscope has been leak-tested to insure watertight integrity.The endoscope has been checked for proper insulation.As a result of this refurbishment, the endoscope has been restored to olympus original factory specifications.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported an evis exera ultrasound gastrovideoscope was found to have a torn bending sheath cover with metal protruding.There is no patient impact related to this occurrence.

Manufacturer Narrative

This report is being updated to provide additional investigation findings.The device history record (dhr) for the complaint device was reviewed, and it was confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user with the following information related to the reported event: ultrasound gastrovideoscope gf-uct180 , chapter 3 preparation and inspection 3.2 inspection of the endoscope.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, protruding objects, or other irregularities.Conclusions: the definitive cause of the reported issue cause could not be identified.Based on the investigation, the following potential causes are presumed: there is a possibility that the bending cover was broken and the metal was protruding because excessive external force was applied to the bending section.Approximately 3 years and 6 months have passed since the device was manufactured, it is possible there was some age related degradation.

• 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: 11094974
• MDR Text Key: 224443231
• Report Number: 8010047-2020-11143
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1