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

Model Number	PBD-203-0707
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was sent to olympus for evaluation.Evaluation of the device found the product and labeling did not match.The product label, barcode label, and triple sticker showed pbd-203-0707, and the pack printing and product body showed pbd-203-0704.Based on the results of the legal manufacturer's investigation, it is likely the product listed on the carton did not match the product body due to multiple products being placed in one sterilization basket and sterilized at the same time.The pbd-203-0704 was then packed as pbd-203-0707, because pbd-203-0704 was mixed in with the pbd-203-0707.However, a definitive root cause could not be determined.A corrective and preventive action (capa) has been opened to further investigate this issue.Olympus will continue to monitor field performance for this device.G3: investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
The customer reported that when inspecting the biliary stent before use during an unspecified therapeutic procedure, the contents of the box were different from the outer box.The intended procedure was completed using another similar device.There was no patient or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information provided by the legal manufacturer.A review of the device history record (dhr) for the subject lot indicated no anomaly with the event-related items.The record includes the following: process inspection sheet, quality inspection sheet.Although there were no anomalies identified in the dhr, the capa (previously mentioned in the initial report) was opened because of the actual discrepancy between the box and its contents due to manufacturing causes.A search was performed to determine whether there were other complaints received for mispackaging of the products, and no other complaints were received for this issue.Activities have been taken to investigate this event and prevent reoccurrence of this event in the future.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be (b)(6) 2021.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14466142
• Report Number: 8010047-2022-08685
• Device Sequence Number: 4516005
• Product Code: FGE
• UDI-Device Identifier: 04953170186370
• UDI-Public: 04953170186370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K933200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2022

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-203-0707
• Device Lot Number: 0XKA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 06/23/2022; 11/08/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 06/30/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown