MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. COLONOVIDEOSCOPE

Model Number	CF-Q150I
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.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 medical systems corp.(omsc) was informed that the user facility noticed the intestinal perforation of the patient during the colonoscopy.The user facility operated the laparoscopic procedure and treated the intestinal perforation for the patient.After the treatment, the patient recovered well and left the user facility without any adverse reactions.
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the subject device.The device history record indicates that the subject device has been shipped in conformity to the specifications.The exact cause of the reported event could not be conclusively determined.Therefore omsc concluded that this phenomenon occurred accidentally.Omsc surmised that this phenomenon is attributed to inappropriate handling by the user.If additional information becomes available, this report will be supplemented.

• 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: 9508730
• Report Number: 8010047-2019-04524
• Device Sequence Number: 2133120
• Product Code: FDF
• UDI-Device Identifier: 04953170229473
• UDI-Public: 04953170229473
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K001241
• 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): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: CF-Q150I
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/22/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other