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

Model Number	JF-140R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus service department found that the forceps elevator was partially detached from the subject device.Other detailed information was not provided such as when the event occurred.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device additional informations.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus europa se & co.Kg.(oekg).Omsc confirmed the following from the evaluation of oekg.The forceps elevator of the subject device is disconnected.There is no shaft connecting the forceps elevator and the distal end.There is no adhesive on the forceps elevator for prevent the shaft from coming off.Also, the detergent/disinfection solution which used to reprocess the subject device was unknown.Based on the past cases, there was the possibility that this phenomenon was attributed to the deterioration of the adhesive due to the influence of the detergent/disinfection solution.The instruction manual of the subject device already instructs; "inspection of the forceps elevator mechanism" perform the following inspections with the bending section in a straight.Inspection for smooth operation turn the elevator control lever slowly all the way in the opposite direction of the ¿ u¿ direction.Visually confirm that the portion of the elevator wire extending from the distal end of the insertion tube is not broken or bent.While observing the forceps elevator at the distal end of the insertion tube, slowly turn the elevator control lever all the way in the ¿ u¿ direction and confirm that the lever can be operated smoothly and that the forceps elevator is raised smoothly.Then slowly turn the elevator control lever all the way in the opposite direction and confirm that the lever can be operated smoothly and that the forceps elevator is lowered smoothly.

• 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
• MDR Report Key: 8815036
• Report Number: 8010047-2019-02633
• Device Sequence Number: 343393
• Product Code: FDT
• UDI-Device Identifier: 04953170339851
• UDI-Public: 04953170339851
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K980465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: No Information
• Device Model Number: JF-140R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1