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

Model Number TJF-160VF

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.Service confirmed a crack on the c-cover due to a physical stress caused by handling.A supplemental will be submitted if additional information becomes available following investigation.Handling of the device is described below in the instruction manual, "do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope 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.".

Event Description

The device was returned to olympus for repair.During evaluation, the repair center identified a crack on the c-cover.There was no patient involvement; the reportable malfunction was found during service.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.A complaint was performed by the legal manufacturer and confirmed one similar complaint with the same event, the same cause, the same device from other user facilities in the past.The legal manufacturer confirmed via dhr that the subject device was shipped in accordance with specifications.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: the legal manufacturer presumed from the following investigation result that the event was due to the impact added to distal end.There was trace of impact added to distal end.C-cover cracked was suggested in a similar complaint, impact (dropped, hit) added to distal end was presumed as its cause.The legal manufacturer reported that the suggested event occurrence was preventable by handling the device in accordance with ifu (operation manual).According to service request order information, the subject device was repaired within a year as follows: on (b)(6) 2020 : c-cover replacement, a-braid replacement, electrical connector reseat, jet tube unit repair.The legal manufacturer referred to the following ifu statements: ifu (reprocessing manual) states how to detect the suggested event as follows.We judged that the event was adequately detected in accordance with ifu in this case.Leakage testing of the endoscope : perform the leakage test : a continuous series of air bubbles emerging from any location on the endoscope indicates a leak at that location.If there is a leak in the instrument channel or suction channel of the endoscope, a continuous series of air bubbles will emerge from one or more channel openings (e.G., distal end, suction connector, suction cylinder, instrument channel port) on the submerged endoscope.Ifu (operation manual) states how to prevent the suggested event.The user handling may have deviated from ifu.However, the legal manufacturer could not specify.Do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope 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.

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10968235
• MDR Text Key: 220247760
• Report Number: 8010047-2020-10029
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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
• Device Operator: Health Professional
• Device Model Number: TJF-160VF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1