MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number SIF-Q180

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus medical systems corp.(omsc), but was returned to olympus (b)(4) for evaluation.In the evaluation of olympus (b)(4) the following was confirmed; the reported event appeared to be caused by incorrect customer's handling.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 Description

Foreign material exited from the biopsy channel of the device.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.Omsc was informed that the foreign material that exited from the biopsy channel was a protective sleeve of the dilation balloon.And the user forgot to remove the protective sleeve when inserting the dilation balloon into the scope.Therefore, the reported event appeared to be caused by incorrect customer's handling of forgetting to remove the protective sleeve from the dilation balloon.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10695253
• MDR Text Key: 211865501
• Report Number: 8010047-2020-07822
• Device Sequence Number: 1
• Product Code: FDA
• UDI-Device Identifier: 04953170339936
• UDI-Public: 04953170339936
• Combination Product (y/n): N
• PMA/PMN Number: K071254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SIF-Q180
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1