MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Crack (1135)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: due to damage on the up/down knob; water tightness is lost, due to a crack on the scope body; water tightness is lost, due to wear of the grip; water tightness is lost, forceps channel port has a dent, air/water cylinder has no color, suction cylinder has no color, switch 1, switch box, connecting tube, and the right/left knob all have a scratch, shaft guide, electrical connector, and the charged coupled device-flexible printed circuit all have corrosion due to water leakage, due to the clogging of the nozzle; no air and water is fed, the objective lens and adhesive around the objective lens have a crack, adhesive around the light guide lens has foreign objects, and the universal cord has coating peeling.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

It was observed that during the device evaluation, the duoendovideoscope distal end cracked.There were no reports of patient involvement.

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, a definitive root cause could not be established.The suggested phenomena were presumed to have been due to physical stress of the device, from which a leak occurred, precluding a proper reprocessing of the device.The instructions for use (ifu) states the detection method for suggested event 1, 3 in ¿operation manual: 3.2 inspection of the endoscope: inspection of the endoscope¿.The ifu states the detection method for suggested event 2 in ¿operation manual: 3.6 inspection of the endoscopic system: inspection of the air-feeding function / inspection of the objective lens cleaning function¿.It is further suggested that the user facility review the method of device handling according to the ifu.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 18661587
• MDR Text Key: 335717190
• Report Number: 9610595-2024-02671
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0379-2022
• Patient Sequence Number: 1