MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DUODENOVIDEOSCOPE

Model Number TJF-150

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation where the reportable malfunction was identified.The repair center found the forceps was functioning as intended, but there was a foreign material on distal end.This defect was due to insufficient cleaning and handling problems.The equipment was repaired and returned to the customer.An olympus (b)(4) capa has been opened to manage the actions related to remediation of this late mdr reporting.

Event Description

The device was returned to olympus for repair.During evaluation, the repair center found a foreign material on the inside of the distal end of the device.There was no report of consequences or impact to the patient.The reportable malfunction was found during service.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint.The lm reported that the cause of the event could not be conclusively determined.The legal manufacturer confirmed that the subject scope was shipped in accordance with specifications via dhr.The legal manufacturer reported that the most likely probable causes are as follows: the legal manufacturer reported that based on the investigation results from the sales business center the cds process at the user facility differed from ifu, and/or deterioration by age caused the suggested event.The adhesive part on the bending rubber is worn out, bending manipulation and insertion tube defects.Insufficient cleaning (handling problems) and defects of the universal cord/distal end/connector/control body.The objective lens was cracked due to a shock caused by dropping and knocking the endoscope to a hard surface/object (handling issue), defects of the universal cord/distal end/connector/control body.The friction plate (f-plate) becomes deteriorated, bending manipulation and insertion tube defects.The parts become loose/ deformed/ damaged/ worn out/ or scratched, air/water leakages or fluid invasion.The switch pc board is damaged, defects of the universal cord/distal end/connector/control body.The angle wires are cut, bending manipulation and insertion tube defects.Bending manipulation and insertion tube defects.The legal manufacturer reported it was presumed that the foreign material remained in the channel for the user handling possibly deviated from ifu.Ifu(reprocessing manual):chapter 3 cleaning, disinfection and sterilization procedures states on how to clean all the channels and forceps elevator in detail.

• Brand Name: 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: 10979602
• MDR Text Key: 227200589
• Report Number: 8010047-2020-10136
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229459
• UDI-Public: 04953170229459
• Combination Product (y/n): N
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1