MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. COLONOVIDEOSCOPE

Model Number	CF-Q150I
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944)
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 was not returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the information from olympus (b)(6), there was the possibility that the damaged channel caused the inappropriate reprocessing and it caused the residual foreign material.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that during the incoming inspection at the service department of olympus (b)(6), it was found that there was foreign material on the channel of the subject device due to the damaged channel.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

• Brand Name: COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10293157
• Report Number: 8010047-2020-04558
• Device Sequence Number: 812416
• Product Code: FDF
• UDI-Device Identifier: 04953170229473
• UDI-Public: 04953170229473
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K001241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2020

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: CF-Q150I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1