MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE COLONOVIDEOSCOPE

Model Number PCF-H290ZI

Device Problems Intermittent Continuity (1121); Corroded (1131); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

E1-address: full name of the establishment is (b)(6) hospital.The subject device was evaluated.Device evaluation found an error e315 (scope err unsupported scope) occurred due to corrosion on the scope connector (an electrical continuity error occurs due to water invasion in the scope connector).The reported issue was confirmed.Furthermore, the following findings were noted during device evaluation: due to wear of angle wire, bending angle in up direction does not meet the standard value.Due to wear of angle wire, the play of up/down knob is out of the standard value.Adhesive on a-rubber has a chip.S-connector is dirty due to water leakage.S-connector and connecting tube has a scratch.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was shipped in accordance with specifications.The root cause of the phenomenon cannot be conclusively identified , however, based on the results of the investigation, the observed failure was due to a defect of the circuit board in the scope connector and probable cause was due to water invasion and corrosion.Olympus will continue to monitor complaints for this device.Supplemental report(s) will be submitted should any relevant new information is available.

Event Description

Customer sent a repair request reported with an issue of" undetectable scope , isolation".The issue found during an unknown event.There was no patient harm, no user injury reported due to the event.

• Brand Name: EVIS LUCERA ELITE COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17300021
• MDR Text Key: 319405709
• Report Number: 9610595-2023-09952
• Device Sequence Number: 1
• Product Code: FDF
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PCF-H290ZI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• 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