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

Model Number PCF-H290ZI

Device Problem Device Handling Problem (3265)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that during reprocessing it was observed that there was an abnormality in the channel.The brush fell out into the forceps channel, and the cutting was carried out.The event occurred two to three days prior to sending the device to olympus for repair.There were no reports of patient harm associated with this event.This report is being submitted for the malfunction of the brush falling off in the forceps channel.

Manufacturer Narrative

Udi not available; device not distributed in us.The device was returned to olympus and the cause of the customer¿s complaint (the brush fell out into the forceps channel) was not confirmed.During testing and inspection, the following was also found: due to wear of the angle wire, the bending angle in the up direction does not meet the standard value.Due to wear of the angle wire the play of the up/down knob is out of the standard value.The connecting tube has a scratch, the control unit is dirty due to water leakage, the control unit has a scratch and is discolored, the adhesive on the bending section cover has a chip, the connector cover has a scratch, the image guide protector has a cut, the switch box has a scratch, due to wear of the scope cover water tightness is lost, the scope cover has a scratch, water tightness is lost due to damage on the up/down knob, scratch on the up/down and left/right knob, the lock engagement lever has a scratch, the universal cord is dirty and has a scratch, paint on the air/water cylinder and scope cylinder is peeled, discoloration of the objective lens due to customer handling, due to a scratch on the objective lens the image has a partially dark area, cloudy image, flare in image, the flexibility adjustment ring has a scratch, the grip is scratched, the forceps channel is shaved, the scope connector and scope connector cover has a scratch.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

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.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely the foreign material occurred due to incorrect reprocessing.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿ 1 inspect the control section and the endoscope connector for excessive scratching, deformation, loose parts, or other irregularities. 1 insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end of the endoscope.Also, make sure that no foreign objects come out of the distal end of the endoscope.2 confirm that the endotherapy accessory can be withdrawn smoothly from the biopsy valve.¿.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16634413
• MDR Text Key: 312254770
• Report Number: 9610595-2023-05186
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H290ZI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• 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