MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. PANCREATIC STENT; PANCREATIC DRAINAGE TUBE

Model Number	PBD-234-0712
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus 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
On (b)(6) 2019 ,the subject device was placed in the pancreatic duct of a patient during endoscopic retrograde cholangiopancreatography.On (b)(6) 2020, ct scan was conducted on the patient and it was confirmed that the subject device was broken and partially missing.There was no patient injury reported.Additional procedures are not planned.This is the report regarding the breakage and missing of the stent.
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.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the stent was damaged due to the material deterioration over time.The above device handling has warned in the instruction manual as follows.After indwelling the stent, periodically evaluate both it and the patient to confirm that there are no irregularities.Otherwise the stent may be damaged due to the material deterioration over time.It may also cause an adverse effect to the patient by clogging, or migrating from the papilla.After indwelling the stent, periodically check the status of the tube and replace it with a new one to confirm there is no irregularity on both the stent and patient.If the tube is improperly positioned, it could contact the duodenal wall and cause perforation, bleeding or mucous membrane damage.The stent may deteriorate over time and could become clogged or fall off of the stent cause it to migrate out of the papilla.

• Brand Name: PANCREATIC STENT
• Common Device Name: PANCREATIC 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: 9864201
• Report Number: 8010047-2020-01840
• Device Sequence Number: 18981563
• Product Code: FGE
• UDI-Device Identifier: 04953170152146
• UDI-Public: 04953170152146
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K021672
• 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): 04/12/2020

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-234-0712
• Device Lot Number: 75K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1