MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE DISTAL ATTACHMENT

Model Number	D-201-10704
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus but the evaluation is in progress.The cause of the reported event cannot be confirmed at this time, however, upon the completion of the device evaluation, this report will be supplemented accordingly.The instructions manual's preparation section instructs users to: always have a spare instrument, use clean, elastic medical tape to secure the instrument to the distal end of the endoscope and to use a grasping forceps to retrieve the instrument if it falls off of the endoscope.To mitigate the risk of device falling off inside the patient, the instruction manual provides warning that states, ¿be sure to wipe away any excess lubricant before mounting the instrument, and secure the instrument firmly using medical tape with sufficient elasticity.If the instrument is not firmly secured, it could come off inside the body cavity during use and cause patient injury, such as mucous membrane damage.¿.
Event or Problem Description
Olympus was informed that during an unspecified procedure, the device (distal end attachment) became detached from distal end of the scope (gif-h190) and fell into the patient¿s oropharynx.The doctor retrieved the device from the patient successfully and the intended procedure was completed.There was no patient injury reported.No additional information was provided from the user facility.
Additional Manufacturer Narrative
This supplemental report is to provide the additional information.The referenced device was not returned, however, the user facility returned a brand new in package device from the same lot.The device was no damage to the package and the seal was intact.The device was removed from the package and a visual inspection found no anomalies on the appearance.The device was then installed onto the distal end of an olympus scope, gif-h190.The device reached the alignment line and was fitted appropriately.The device was observed to remain attached and secured to the distal end of the scope and would not come off when gently pulled.Based on the evaluation, the cause of the reported event cannot not be conclusively determined as the used device was not returned and the brand new device passed the inspection and functioned as designed.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: DISPOSABLE DISTAL ATTACHMENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8377166
• Report Number: 2951238-2019-00467
• Device Sequence Number: 11167863
• Product Code: FDS
• UDI-Device Identifier: 04953170278266
• UDI-Public: 04953170278266
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: D-201-10704
• Device Lot Number: 8YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1