MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-HQ190

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The evaluation found foreign glue was found coming from the suction channel and from inside the biopsy channel port.Additionally, the bending section cover adhesive was found peeling and the one of the light guide lens at the distal end was cracked.The scope was repaired to specification and returned to the customer.A review of the scope's repair history indicates the scope was last serviced via repair on july 6, 2020 due to an error 216.As part of the investigation, olympus followed up with the customer to obtain additional information regarding the reported event.The customer further reported the event was first during a gastroscopy procedure.The patient was undergoing an unspecified gastroscopy.There was no failure and no patient injury, infection or medical intervention associated with this event.The facility did not document it as it is expected to happen when using glue.The foreign substance was gluebran-medical glue.It was inserted inside the scope via the instrument channel and found during service inspection (at oci).No olympus validation on any glue.The glue is intended to be applied inside the patient.The same device was used to complete the procedure.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed, the evis exera iii gastrointestinal videoscope was noted to have "glue inside the channel"; foreign material exited from the channel.No patient injury or harm was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct the date the device was manufactured.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, the reported issue was found to be caused by the glue adhering to/remaining in the suction channel after the user suctioned the medical glue used during the procedure from inside the patient's body.The following warning is stated in the device's instructions for use: "avoid aspirating solid matter or thick fluids; instrument channel, suction channel, or suction valve clogging can occur.If the suction valve clogs and suction cannot be stopped, disconnect the suction tube from the suction connector on the endoscope connector.Turn the suction pump off, detach the suction valve, and remove solid matter or thick fluids.".

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11257683
• MDR Text Key: 231708758
• Report Number: 8010047-2021-02078
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1