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

Model Number GF-UCT180

Device Problem Failure to Clean Adequately (4048)

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

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

During the inspection of the returned device, the device failed the leak test and there were worn angle wires and the up/down knob could not be locked securely (due to the forceps elevator being deformed).Scratches were found on the connecting tube, universal cord, universal cord protector on the side connector (the side connector side on the control body), the side connector on the control body, side cover on the control body, distal end, light guide cover glass, switch box button #1, forceps channel, grip, control unit and the acoustic lens.The side cylinder, bending section cover and light guide lens were found to be dirty.In addition, the adhesive on the bending section cover was detached, the light guide bundle has breakage and the water tightness was lost.The device failed the water removal inspection.The nozzle/forceps elevator was noted to have debris.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the knob on the evis exera ii gastrointestinal videoscope was leaking.The device also had low angulation and was experiencing angulation play.During the inspection of the returned device, the nozzle/forceps elevator was obstructed with debris, which was attributed to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Event Description

During the inspection of the returned device, the forceps elevator was obstructed with debris, which was attributed to insufficient cleaning.

Manufacturer Narrative

This supplemental report is submitted to provide applicable corrections regarding the device evaluation.The forceps elevator was noted to have debris at the distal end.

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.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, the event likely occurred because the foreign material that adhered to the forceps elevator during the procedure could not be removed by reprocessing.The specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is submitted to provide the additional information from the user facility.

Event Description

The event was observed during reprocessing.

• 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: 13085551
• MDR Text Key: 286674528
• Report Number: 8010047-2021-16828
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2021
• 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: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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