MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE NASAL BILIARY DRAINAGE TUBE V

Model Number	PBD-V811W-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 -complete address - (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that post an unknown therapeutic procedure, perforation of the bile duct was identified.The procedure was completed with the same device.Follow-up for further event details has been conducted and no more information is available at the time of the report.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's (lm) investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject device was reportedly discarded and not available for an evaluation by olympus.Based on the results of the investigation, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which states: ¿before each procedure, prepare and inspect the instrument as instructed below.Inspect other instruments to be used with this instrument as described in their respective instruction manuals.Should any irregularity be observed, do not use the instrument, contact olympus.Damage or irregularity may compromise patient or user safety, potentially causing such results as infection control risk, tissue irritation, perforation, bleeding or mucous membrane damage, as well as possibly resulting in more-serve equipment damage.¿ ¿do not insert the instrument into the endoscope unless you have a clear endoscopic field of view.If you cannot see the distal end of the instrument in the endoscopic field of view or in x-ray images, do not use it.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It may also damage the endoscope and/or instrument.¿ ¿be sure to hold the guidewire when inserting the instrument.Otherwise, it will move with the instrument.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.¿ ¿do not angulate the bending section of the endoscope or operate the forceps elevator abruptly while the distal end of the instrument is extended from the distal end of the endoscope.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.¿ ¿do not force the distal end of the instrument against body cavity tissue.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.¿ ¿do not force the instrument if resistance to insertion is encountered.Reduce the angulation or lower the forceps elevator until the instrument passes smoothly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It may also damage the endoscope and/or instrument.¿ ¿do not extend the instrument abruptly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It may also damage the endoscope and/or instrument.¿ ¿raise the forceps elevator to its maximum height when inserting the instrument into the endoscope.If the forceps elevator is down, you will not be able to see the distal end of the insertion portion in the endoscopic field of view.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.¿ ¿do not forcibly insert the instrument into the papilla of vater.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.¿ this supplemental report includes additional information received from the customer.Therefore, information has been added to b2, b5, and h6.Also, a correction has been made to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the perforation of the bile duct occurred after an endoscopic nasobiliary drainage procedure.Although requested, the facility reported that the cause of the perforation cannot be identified because the subject device was discarded.The patient required a second surgery to treat the perforated bile duct.Currently, the patient is reportedly in good condition.

• Brand Name: SINGLE USE NASAL BILIARY DRAINAGE TUBE V
• Common Device Name: SINGLE USE NASAL BILIARY DRAINAGE TUBE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20747219
• Report Number: 9614641-2024-02108
• Device Sequence Number: 8363050
• Product Code: FGE
• UDI-Device Identifier: 04953170309410
• UDI-Public: 04953170309410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PBD-V811W-07
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: KD- V411M-0725, SPHINCTEROTOME, SN-UNK
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown