MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER

Model Number CV-180

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.As part of our investigation, a field service engineer (fse) has been scheduled to visit the customer¿s site to evaluate the equipment.The cv-180 instruction manual states ¿ if the video system center is visibly damaged, does not function as expected, or is found to have irregularities during the inspection described in chapter 3, ¿inspection¿ and chapter 8, ¿installation and connection¿, or the use described in chapter 4, ¿operation¿, do not use the video system center and contact olympus.Some problems that appear to be malfunctions may be correctable by referring to section 10.1, ¿troubleshooting guide¿.If the problem cannot be resolved by the described remedial action, stop using the video system center and contact olympus.¿.

Event Description

The service center was informed that during an unspecified procedure, the screen intermittently froze and displayed ¿mecha trouble: process 62¿ message.The screen also froze while the doctor was advancing the scope in the patient.There was a mechanical issue and the doctor pressed restore memory images but no pictures printed.It was reported that the device settings had not been changed in five years.The tech performed the same steps as usual.The device was illuminated and required troubleshooting.There were no other devices used in the procedure.It is unknown if the intended procedure was completed.There was no patient injury reported.Additionally, the user facility reported that the device was setup according to the manual.However, the device did display an error ¿52¿ in an previous procedure.The doctor was experienced in using this equipment.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and manufacturer date.The raised event was probably caused by a single device operation due to aged deterioration of cv-180 based on the following information.The device had passed 11 years since the manufacture of this device.

• Brand Name: EVIS EXERA II VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9930164
• MDR Text Key: 207390750
• Report Number: 8010047-2020-02012
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1