MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center found in addition , due to deformation of video connector, water tightness is lost.The nozzle has a dent and burr.The distal end has a scratch and crack.The adhesive on the bending section cover has a scratch and discoloration.The connecting tube has discoloration, a scratch and a wrinkle.The scope cylinder is shaved and scope connector cover has a scratch.The switch box has a scratch, lock engagement knob is deformed and universal cord is dirty.Due to wear of angle wire, bending angle in up/down/right/left direction and knob does not meet the standard value.Water removal ability does not meet the standard value due to deformation of nozzle.A definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The user facility reported to olympus the colonovideoscope had play in upward/downward angulation control knob, leakage from the biopsy channel, the coat was peeling, bending manipulation and insertion tube defects.Upon inspection and testing of the returned device, it was observed that the nozzle had foreign material which occurred from insufficient cleaning.This report is being submitted for the event found during estimation.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the customer.
Event or Problem Description
Customer confirmed the event was found during reprocessing of the device and did not involve any procedure or patient.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 04-jan-2022.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, it is likely the nozzle was clogged with foreign materials such as gauze because of inappropriate reprocessing after previous procedure.The event can be detected/prevented by following the instructions for use which state: :inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.".Olympus will continue to monitor field performance for this device.

• Brand Name: COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13347739
• Report Number: 8010047-2022-01960
• Device Sequence Number: 11200480
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2022

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: 01/04/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 04/21/2022; 06/10/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 05/20/2022; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2014
• 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