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

Model Number GF-UCT180

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

The inspection found a gap was between the distal end probe cover and pink colored/acoustic lens as a portion of the adhesive was peeled off, cracked and missing.Additionally, the distal end/bending section cover glue was defective and the glue was set too high.The bending section cover, has wear and tear; the switch 1 is cut.The biopsy channel is deformed, scratched; seat holder unit is clogged; the air/water separator came off, defective.The el-connector unit, the shield plate and ultrasonic connector are corroded.The ultra sound image has 5 broken ultra sound elements; very slight shadow at approximately 7 o'clock position.The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The service center was informed that a customer evis exera ii ultrasound gastrovideoscope was returned to the regional repair center (ode) due to a report of , "the working channel is not aligned with the transducer and the needle is not visible on the ultrasound image" observed during an unspecified event.During inspection and testing, a gap was found between the distal end probe cover and pink colored/acoustic lens as a portion of the adhesive was peeled off, cracked and missing.No patient injury or harm was reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the cause of the gap in the adhesive at the distal end likely occurred due to excessive force applied to the distal end.The specific root cause could not be determined at this time.The following information is stated in the instructions for use: "do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 01-nov-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12957226
• MDR Text Key: 283096389
• Report Number: 8010047-2021-15682
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

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: 11/10/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 03/21/2022; 11/08/2022
• Supplement Dates FDA Received: 04/18/2022; 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2014
• 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