MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. COLONOVIDEOSCOPE

Model Number	CF-LV1L
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date is (b)(6) 2022.The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that the nozzle had foreign material.Other observations for the device are: objective lens has a scratch; distal end has corrosion; adhesive on distal end rubber coating (a-rubber) is detached; connecting tube has a wrinkle and a scratch; up/down knob is dirty; s-connector and plug unit have corrosion; due to wear of angle wire, bending angle in up direction does not meet the standard value; due to deformation of bending tube, the play of knobs is out of the standard value; and due to deformation of nozzle, water removal ability does not meet the standard value.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
Event or Problem Description
Customer returned the device for inspection.There is no reported harm to any patient.Upon evaluation of the returned device, it was observed that the nozzle had foreign material.This medwatch is being submitted for the issue of foreign material found in the nozzle during device evaluation.
Additional Manufacturer Narrative
Correction to the initial medwatch.The aware date should be 06-mar-2022.Correction to the initial medwatch.The event date is unknown.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, a definitive root cause could not be determined.However, it is likely that body fluids and chemical solutions clogged in the nozzle because of inappropriate reprocessing after the previous procedure.The following is included in the instructions for use (ifu) and may help detect or prevent the event: "inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities"."warning: if the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy.Preclean the endoscope and the accessories at the bedside immediately after each patient procedure."flush the air/water channel with water and air_ caution: to prevent clogging of the air/water nozzle, always use the aw channel cleaning adapter to clean the air/water channel after each use." "thoroughly brush or wipe all external surfaces of the endoscope, using a clean lint-free cloth, brush, or sponge.Pay particular attention to the air/water nozzle opening and the objective lens on the distal end of the insertion section, and confirm that all debris is removed from all surfaces of the distal end." "rinse the endoscope and accessories" "caution: follow the steps below only in cases of excessive bleeding and/or delayed reprocessing; unnecessary immersions should be avoided.Consecutive reprocessing sessions using extended immersion may damage the endoscope." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Additional information has been received for this event.This supplemental report is being submitted to provide this information.Please see the updates in sections: d5, e1, e2, e3, g2, g3, g6, h2, and h10.Olympus field service engineers (fse) have provided correct reprocessing training to user during installation and routine visits, but user has not followed correct reprocessing methods for the device.Information on reprocessing performed at the facility: an air water channel cleaning adapter is not used for pre-cleaning.Pre-cleaning is partially performed immediately after a procedure.Steps followed at the facility for pre-cleaning are as below: 1.Wipe the insertion tube with water and non-enzymatic detergent.2.Suction of 30 seconds for water and non-enzymatic detergent.The endoscope channels brushing during manual cleaning is being done sometimes and being done partially.Brushing is done with olympus reusable brush bw-20t through biopsy port to distal end direction.Facility is not using mh-507 brush.Cleaning and disinfectant solutions used with the endoscope are johnson and johnson model cidex.No automatic endoscopy reprocessor (aer) is being used to reprocess the endoscope, only manual cleaning is performed.The endoscope is stored in non ventilated scope cabinet with support of scope hanger.
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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to the user's understanding of reprocessing being different from the recommendations provided within the instructions for use (ifu).The user can detect the event properly by handling device in accordance with the following ifu: "reprocessing manual_precleaning the endoscope and accessories.Flush the air/water channel with water and air_ caution: to prevent clogging of the air/water nozzle of the endoscope, flush water into the air channel of the endoscope, using the a/w (air/water) channel cleaning adapter (mh-948) after each patient procedure.Storage and disposal_ precaution of storage and disposal caution: to prevent damage, do not store the endoscope and/or accessories in direct sunlight, at high temperatures, in high humidity, or exposed to x-rays or ultraviolet rays." olympus will continue to monitor field performance for this device.
Event or Problem Description
During investigation of the suggested phenomenon of "nozzle has foreign objects" it was determined that the device was incorrectly reprocessed.

• 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: 13955568
• Report Number: 8010047-2022-05380
• Device Sequence Number: 4882543
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2022

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: 03/06/2022
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 04/11/2022; 09/01/2022; 09/09/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/09/2022; 09/01/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2015
• 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