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

Model Number	CF-LV1L
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to the reportable malfunction documented in b5, the additional evaluation findings are as follows: distal end had a dent, nozzle was shaved, due to wear of angle wire, bending angle in down direction did not meet the standard value, due to wear of angle wire, bending angle in left direction did not meet the standard value, due to wear of angle wire, bending angle in right direction did not meet the standard value, due to clogging of nozzle, water removal ability did not meet the standard value, control unit had discoloration, connecting tube had a buckling, grip had a scratch, due to wear of angle wire, the play of upward/downward knob was out of the standard value, universal cord had a scratch , due to damage on charged coupled device unit, the image had shadows, adhesive on bending section cover was detached, no angulation when angulation control knob was turned, right/left knob had discoloration, grip had discoloration, due to wear of angle wire, bending section cannot be bent in up direction at all, distal end was shaved, due to wear of angle wire, the play of right/left knob was out of the standard value.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The olympus field service engineer reported (on behalf of the customer) that there was no upward/downward angulation on the colonovideoscope.The issue was found during an unspecific procedure.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the bending section cover had foreign material.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional 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 foreign material could not be identified nor the root cause of it.The event can be detected/prevented by handling the device in accordance with the following instructions for use: cf-lv1l/i,operation manual chapter 3 preparation and inspection states how to detect the event.Cf-lv1l/i,reprocessing manual chapter 5 reprocessing the endoscope(and related reprocessing accessories) states how to prevent the event.Olympus will continue to monitor field performance for this device.

• Brand Name: COLONOVIDEOSCOPE
• Common Device Name: 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: 18107151
• Report Number: 9610595-2023-16854
• Device Sequence Number: 14842035
• Product Code: FDF
• UDI-Device Identifier: 04953170312397
• UDI-Public: 04953170312397
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: CF-LV1L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown