MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8019S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Septic Shock (2068)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature titled: endoscopic ultrasound-guided hepaticogastrostomy versus hepaticogastrostomy with antegrade stenting for malignant distal biliary obstruction." literature summary: recurrent biliary obstruction (rbo) is a possible complication of endoscopic ultrasound-guided hepaticogastrostomy (eus-hgs) in patients with malignant distal biliary obstruction (mdbo).Methods: we retrospectively evaluated consecutive patients who underwent eus-hgs or hgas.The trbo, overall survival (os), and adverse event (ae) rate were compared between the groups.Results: this study included 96 patients (eus-hgs, n = 58; hgas, n = 38).There was a significant difference in the cause of endoscopic retrograde cholangiopancreatography failure and the hgs stent type between the groups.Conclusions: endoscopic ultrasound-guided hepaticogastrostomy prolonged the trbo compared with eus-hgs for biliary drainage in patients with mdbo.Type of adverse events/number of patients: recurrent biliary obstruction - 20 patients.Peritonitis - 5 patients.Cholangitis - 2 patients.Pancreatitis - 5 patients.Bleeding - 2 patients.Death 10 days after onset of septic shock - 1 patients.Pseudoaneurysm - 2 patients.Death in the follow up - 97 patients (not reportable).Na-u200h-8019s was selected because a 19-gauge version of the ez shot 3 plus was used.This article includes 6 complaints as follows: (b)(6) :na-u200h-8019s (septic shock/death).(b)(6) :na-u200h-8019s (for adverse events only).(b)(6) :gf-uct260 (septic shock/death).(b)(6):gf-uct260 (for adverse events only).(b)(6):jf-260v (septic shock/death).(b)(6) :jf-260v (for adverse events only).This report is 1 of 6 for (b)(6) :na-u200h-8019s for the death of 1 patient 10 days after onset of septic shock.
Event or Problem Description
The author provided additional information: the olympus serial/lot numbers are unknown.The adverse events and deaths were not cause or contributed by an olympus device.The adverse events and deaths are attributed to an exacerbation of the disease.The device is not available for return.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: h6, h10.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.No malfunctions were reported.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15294373
• Report Number: 9614641-2022-00207
• Device Sequence Number: 12338269
• Product Code: FCG
• UDI-Device Identifier: 04953170380440
• UDI-Public: 04953170380440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: NA-U200H-8019S
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK SERIAL: (B)(6)
• Outcome Attributed to Adverse Event: Other; Death
• Patient Sex: Unknown