MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE BILIARY STENT V

Model Number	PBD-V621R-1005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.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.*during an endoscopic biliary drainage, the subject device was used.When the user tried to exchange the device for a new one, the user found that the flap on the bile duct side was broken off and the device migrated inside the bile duct.The device was retrieved from the bile duct to the duodenum with a balloon.The intended procedure was completed with another device.There was no patient injury reported.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Only the stent was sent.All four flaps (rear end side) on one side of the stent were broken.No fragment was sent.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the event date, it was found no irregularities.Previous similar cases have shown that the side flaps possibly deteriorated due to digestive fluid or internal environment of the patient.The side flaps might have deteriorated due to the chemical effects of digestive fluid and the mechanical effects of peristalsis, causing the side flap damage.The above device handling has warned in the instruction manual.

• Brand Name: SINGLE USE BILIARY STENT V
• Common Device Name: SINGLE USE BILIARY STENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10745642
• Report Number: 8010047-2020-08228
• Device Sequence Number: 11591288
• Product Code: FGE
• UDI-Device Identifier: 04953170185175
• UDI-Public: 04953170185175
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K933200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: PBD-V621R-1005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1