MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BILIARY DRAINAGE TUBE

Model Number	PBD-421-1005
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
We received the following report.The user encountered more frequent problems with double-layer-drains for the bile duct.Since the distal flaps detached several times, the drain was dislocated and more difficult to retrieve even 3-4 months after insertion due to material weakness.There was no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.According to the provided photo, omsc confirmed that one side flap was deteriorated and the whole stent became black.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past two years from the event date, it was found no irregularities.Based on the past similar cases, it was known that the side flaps were deteriorated and broke due to chemical effects such as digestive fluid or mechanical effects such as peristalsis.The above case has warned in the instruction manual.

• Brand Name: BILIARY DRAINAGE TUBE
• Common Device Name: DRAINAGE TUBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10506274
• Report Number: 8010047-2020-06320
• Device Sequence Number: 19150021
• Product Code: FGE
• UDI-Device Identifier: 04953170046926
• UDI-Public: 04953170046926
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K933200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: No Information
• Device Model Number: PBD-421-1005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1