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

Model Number	PBD-421-1005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the patient's internal environment such as chemical effect of digestive fluid or mechanical effect of peristaltic action caused the degradation and breakage of the flaps.It is likely that the stent moved because the side flaps were broken.The instruction manual of the device has already warned as follows: after placing the drainage tube in the duct, closely monitor the condition of the patient.Also periodically check the condition of the drainage tube (to see if the lumen of the tube is not clogged, and if there are four side flaps in the side of the duodenum, etc.) and the condition of implantation of the tube (to see if the position of the tube has not changed).In case of irregularities or unnecessary retention of the drainage tube, remove the drainage tube using grasping forceps.If necessary, periodically exchange the drainage tube.The drainage tube may deteriorate over time and could become clogged.The status of the drainage tube can change with the condition of the patient (e.G., inflammation, remittance of biliary tract stenosis, etc.).The drainage tube may deteriorate over time, causing the side flap(s) to break or detach completely (reports have been received on side flaps coming off several months after placement).Deterioration or damage to the drainage tube may result in erosion of the duodenal wall, biliary tract obstruction, detachment of the drainage tube part migrating into the duct or out of the papilla, mucous membrane damage, perforation, or bleeding.In the medical literature, occurrences of drainage tube dislocation have been reported in 3.3 ¿ 13.3% of patients.Immediately remove the drainage tube if dislocation is detected.When the drainage tube in the duodenal side is damaged and fragments such as flaps come off inside the duodenum, use grasping forceps for retrieval.Also, for fragments remaining in the bile duct side, use grasping forceps for retrieval and then replace the drainage tube with a new one.When the drainage tube in the bile duct side is damaged and fragments such as flaps come off inside the bile duct, use grasping forceps to retrieve the drainage tube.If necessary, replace it with a new one.To retrieve the flaps etc.That fell off, use grasping forceps or a retrieval basket etc.While checking the x-ray images.
Event or Problem Description
On (b)(6) 2018, the subject device was placed in the bile duct of a patient with cholangitis.On (b)(6) 2019, the bile duct was checked for stent replacement.It was found that the flaps of the subject device were missing and the subject device was migrated.The subject device was retrieved and discarded by the user.There was no patient injury reported.No further information was provided.This is the report regarding the migration of the device and the missing of the flaps.

• 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: 8427754
• Report Number: 8010047-2019-01303
• Device Sequence Number: 11098086
• Product Code: FGE
• UDI-Device Identifier: 04953170046926
• UDI-Public: 04953170046926
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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
• Report Date (Section B): 03/18/2019

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: No Information
• Device Model Number: PBD-421-1005
• Device Lot Number: 6YK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1