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

Model Number	PBD-1030-0805
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus¿s local distributor, but not returned to omsc.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed quality manager of olympus (b)(4) that there was liquid in the package of the subject device before an unspecified procedure.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This supplemental report are being submitted to correction and additional information.Correct the component codes of h6 from "515 stent" to "4747 packaging".In the evaluation of omsc the following was confirmed, the model number was pbd-1030-0809.The device lot number was 09k.No foreign material was found in the sterile package.No abnormality such as peeling of the heat sealed area was confirmed.A transparent sticker had been applied to the film side of the sterile package.Air bubbles were observed in between the film side and the sticker.Air bubbles disappeared after the sticker was removed.No other abnormalities were observed.The device history records for this lot number indicated no abnormalities related to the phenomenon you pointed out: packaging condition: the packaging must be in the specified condition.The content of the instruction manual was confirmed.However, the instruction manual did not contain the descriptions related to the reported event.There have been no reports of the same complaints from other facilities.Inside the package and heat-sealed area presented no abnormalities.Based on the condition of the subject device, it is possible that the transparent sticker had been applied to the film side of the sterile package.This might have caused the air bubbles in between the film and the sticker.These bubbles possibly looked like foreign materials (liquid).Upon shipment the device from aomori factory, no stickers had been applied to the film side of the sterile package.Therefore, the sticker had been possibly applied after shipment.

• Brand Name: SINGLE USE BILIARY DRAINAGE STENT V
• Common Device Name: SINGLE USE BILIARY DRAINAGE STENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11676286
• Report Number: 8010047-2021-04998
• Device Sequence Number: 3511402
• Product Code: FGE
• UDI-Device Identifier: 04953170345982
• UDI-Public: 04953170345982
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K103478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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-1030-0805
• Device Lot Number: 09K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1