MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS DUODENOVIDEOSCOPE

Model Number	JF-140R
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 suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center confirmed the reported event and the k-wire was found cut from the distal end.There was a scratch on the sub-control unit and water tightness is lost, there is deformation of a connector, grip is sticky, grip has scratch, switch box has scratch, suction cylinder is shaved knob is deformed, suction cover has scratch, universal cord is scratched, light guide cover glass has a scratch, bending tube deformed, and forceps does not rise up at all.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported to olympus, during preparation for use, the elevator wire was cut off.The device was returned for repair and the forceps elevator was found to have foreign material and the inside of the light guide lens was dirty.These are reportable events.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 28-dec-2021.This report is being supplemented to provide additional information received from the reporter and 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.The user provided their cleaning disinfection and sanitization practices where: ¿ oer-aw re-processor is used.¿ detergent used is not known.¿ for forceps elevator no brush is used for disinfection, customer uses glutaraldehyde.¿ normal water for rinsing.Based on the results of the investigation, the following likely caused the event: since the forceps elevator could not be operated due to the broken k-wire, reprocessing was insufficient.Due to the bending section rubber leak, reprocessing after the leak test was not performed.Due to the bending section rubber leak, moisture invaded the device and caused corrosion.The corrosion remained as foreign material.Delayed reprocessing, storage environment, substance from used chemicals, and others.The root cause of why the device was not reprocessed according to the device ifu could not be determined.The following is included in the ifu and may have helped prevent the event: ¿all channels of the endoscope, including the elevator wire channel where fitted, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.¿ ¿thoroughly clean and high-level disinfect or sterilize the endoscope before returning it for repair.Improperly reprocessed equipment presents an infection control risk to each person who handles the endoscope within the hospital or at olympus.¿ "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient." "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: EVIS DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• 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: 13357303
• Report Number: 8010047-2022-02000
• Device Sequence Number: 4737946
• Product Code: FDT
• UDI-Device Identifier: 04953170339851
• UDI-Public: 04953170339851
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K980465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: JF-140R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• 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: 12/30/2021
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2013
• 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