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

Model Number GF-UCT180

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

The subject scope was returned to the service center.The evaluation found the scope produced a white glare on the image.Additionally, the ultrasound probe unit at the distal end was damaged; pink colored rubber was loose and the adhesive on the distal end cover was missing.There were 15 broken elements on the ultrasound image, the elevator inlet was loose, and the control knobs were loose.The scope passed the leak test.The scope was repaired back to standard specifications and returned to the customer.A review of the repair history indicated the scope was last serviced via repair on (b)(6) 2020 due to a leak.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

The service center was informed that the evis exera ii ultrasound gastro-video scope's image field was blacked out.No patient injury or harm was reported.

Manufacturer Narrative

The bottom middle screen was shadowed occurred during a therapeutic gastroscopy and upper endoscopy.No other devices were involved in the event and there was no delay in the procedure.The procedure was completed with the same device.There was no impact to the patient or procedure.Connections and settings were checked and found to be correct.The camera head functioned when plugged into other towers and the tower functioned when other camera heads were plugged in.No error codes were displayed.The device was inspected prior to use and no damage was observed.The investigation is ongoing; however, if additional information becomes available, this report will be supplemented accordingly.

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 (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause is likely the peeling from deterioration over time based on the device manufacture date.Additionally, it is likely that the peeling of glue on the forceps cover and the looseness of the probe unit cover occurred due to an external force application, such as strong rubbing against the subject part during normal use, including re-processing.This issue is addressed in the instructions for use (ifu): "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, protruding objects, or other irregularities." per the legal manufacturer, the other device defects included in the initial mdr (broken elements and loose components) have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

• 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: 11013452
• MDR Text Key: 227199825
• Report Number: 8010047-2020-10397
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS CLV-190 LIGHT SOURCE; OLYMPUS CV-190 VIDEO PROCESSOR
• Patient Age: 71 YR
• Patient Weight: 66