MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H170

Device Problems Mechanical Problem (1384); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The (obl) servicing group was informed by the user facility that their gastro-intestinal videoscope was returned for service due to a report of "slack in the handles since it was purchased".Upon inspection and testing, the endoscope was observed to have signs of insufficient cleaning due to a foreign material found inside/exiting the instrument channel.No patient injury or harm was reported to olympus.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The local repair evaluation found the suction channel with foreign waste inside.Additionally, the angulation wires are stretched, the insertion tube cover was deteriorated due to accumulation of waste and was melted, the insertion tube has shape and structure deformation and bending section cover glue is peeling off and brittle.The legal manufacturer performed a review of the device history records for the concerned device and no abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The exact cause of the reported foreign material exited the channel could not be conclusively determined.The potential cause of the reported malfunction is due likely due to the following: the user did not adequately brush or feed sufficient water at pre-cleaning or manual cleaning.- pre-cleaning to be taken immediately after procedure was delayed, which caused foreign material to adhere and remain within the suction channel.- reprocessing process at the facility differed from ifu recommendation.As stated on the ifu (reprocessing manual) and as a preventative measure the ifu states, - precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.- manually cleaning the endoscope and accessories: be sure to thoroughly brush the inside of the instrument channel, the instrument channel port, the suction channel, and the suction cylinder of the endoscope.Insufficient brushing may pose an infection control risk.Olympus will continue to monitor complaints for this device.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12290711
• MDR Text Key: 265577777
• Report Number: 8010047-2021-09920
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170334115
• UDI-Public: 04953170334115
• Combination Product (y/n): N
• PMA/PMN Number: K112680
• 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: 09/29/2021

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: GIF-H170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1