MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-XZ1200

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

An olympus marketing personnel reported on behalf of the customer that the gastrointestinal videoscope forceps got caught during insertion/removal.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation of ¿forceps got caught during insertion/removal was not confirmed.The device evaluation found due to wear of the angle wire, bending angle in up direction did not meet the standard value.Due to wear of angle wire, the play of up/down knob was out of the standard value.The adhesive on the bending section cover was chipped and had a white-clouded area.The channel tube had a scratch, the plastic distal end cover had a scratch.And the control unit was damaged.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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 investigation, the root cause of the event could not be identified although it can be presumed that the defect was caused by stress of repeated use, external factors, or handling.The event can be detected/prevented by following the inspection method for the event is described as follows in the operation manual: ¿chapter 4 operation, 4.2 insertion¿ [warning] if the suction valve clogs and the suction cannot be used when solid matter, such as the clip or thick fluid, are aspirated, withdraw the endoscope and disconnect the suction tube from the suction connector on the endoscope connector.Attach a syringe containing sterile water to the suction connector.Straighten the insertion tube as much as possible and forcefully flush the connector with the water while the suction valve of the endoscope is slightly depressed.Repeat the flush until the thick fluid or solid matter is discharged from the distal end of the suction channel.After discharging, confirm that there is no irregularity in the suction function according to ¿inspection of the suction function¿ on page 60, before using the endoscope again.If the thick fluid or solid matter cannot be discharged, stop using the suction function and contact olympus.Olympus will continue to monitor field performance for this device.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18004726
• MDR Text Key: 326917053
• Report Number: 9610595-2023-15857
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XZ1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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