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 01/07/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for annual inspection, and the evaluation found the reportable malfunction of the distal end had a crack.The following non-reportable findings were found during device evaluation: grip had a scratch, air/water cylinder had no color, suction cylinder had no color, switch box had a scratch, right/left knob had discoloration, upward/downward angulation control knob had discoloration, water tightness was lost because guide pin of electrical connector was shaved, scope connector cover unit had a scratch, scope connector had a scratch, sheet holder unit had corrosion due to water leakage, light guide lens had a chip, adhesive around light guide lens had a crack, connecting tube had a scratch, adhesive around objective lens had a crack, and universal cord had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was observed that during the device evaluation, the duodenovideoscope exhibited a crack on the distal end.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.The device was visually inspected, and functional testing was performed.The device did not meet the standard specifications and functions.Based on the results of the investigations, the gap between z-block and c-body was confirmed.The probable cause was determined as due to physical stress such as hitting/dropping distal end or chemical stress such as chemical solution used.However, the root cause of the suggested event could not be specified.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: 18583047
• MDR Text Key: 333824072
• Report Number: 9610595-2024-01640
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/21/2024

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: 01/21/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2012
• 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