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

Model Number GF-UCT180

Device Problem Material Separation (1562)

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

The customer reported that the scope was leaking at the flushing channel.There was no reported patient involvement.The device was returned to the regional repair center (rrc) and found a gap on the probe¿s distal end adhesive.This report is being submitted to address the distal end gap found on the probe¿s adhesive.

Manufacturer Narrative

The event date is (b)(6) 2021, when the gap in the adhesive was noted on the scope¿s probe.The reporter¿s contact information, occupation and health profession are unknown at this time.Further inspection of the returned evaluation noted the mouthpiece pin detached from the electrical connector unit.A leak was noted at the electrical connector.The scope body was found damage and leaking.Damage was noted on the acoustic lens.A cementing defect was noted on the bending section rubber.The scope cover was found broken.The paint was peeling off the suction cylinder nut.Play was noted on the angulation wire.Scratches were noted on the scope¿s charge-coupled device, charge-coupled device cover lens, switch box unit, connecting tube.Deposit was noted on the insertion part of the connection tube.The cause of the physical damage to the scope cannot be determined at this time.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received 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 found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, several damages were observed in the distal end.Therefore, it was determined that external force was likely applied to the distal end.It was determined that stain could enter inside the lens through the gap due to the adhesive peeling off, or was cracked due to a shock caused by dropping and knocking the endoscope to a hard surface or object (handling issue).It was surmised that wear and tear damage with customer mishandling and with increased use/time also contributed to the event.The instruction manual identifies the following related verbiage which can help prevent the phenomenon: ¿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.

• 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: 13011471
• MDR Text Key: 286438486
• Report Number: 8010047-2021-16181
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

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: 11/17/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 01/23/2022
• Supplement Dates FDA Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• 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