MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Peritonitis (2252); Unspecified Gastrointestinal Problem (4491); Unspecified Hepatic or Biliary Problem (4493)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed a literature titled "eus-guided hepaticoenterostomy with using a dedicated plastic stent for the benign pancreaticobiliary diseases: a single-center study of a large case series".Literature summary: the aim of the present study was to evaluate the usability of dedicated plastic stents for eus-hes in patients with benign pancreaticobiliary diseases.The overall technical success rate of eus-hes was 92.9% (53/57).Among the 4 cases of technical failure of plastic stent placement, a sems was placed in 1; percutaneous transhepatic biliary drainage was performed in 1; eus-hes was reperformed 1 week later in 1; and observational management was selected in 1 patient.Adverse events associated with the procedure were seen in 15.7% (9/57) of the patients, namely, biliary peritonitis in 4, bleeding in 2, cholecystitis in 2, and pneumoperitoneum in 1 patient.Except for 1 patient who required blood transfusion owing to bleeding and 1 patient with cholecystitis who required percutaneous transhepatic gallbladder drainage, the other 7 patients were treated by conservative therapy.One patient with clinical failure required additional insertion of a nasobiliary drainage tube owing to the recurrence of cholangitis, which was placed alongside the plastic stent on the postprocedure day 11.Moderate aes were seen in 15.8% (9/57) of the patients, which included bleeding in 2, peritonitis owing to bile juice leakage in 4, cholecystitis in 2, and pneumoperitoneum in one patient.A 19g needle was used in both two patients in whom bleeding occurred, and one patient required a blood transfusion.This patient had been bleeding tendency owing to coagulopathy resulting from liver failure.Vitamin k2 was administered before the eus-hes to prevent bleeding.However, owing to the stiff liver wall, this patient was required to use the multiple tract dilation, including cautery dilator.This patient vomited fresh blood and was in hypovolemic shock 6 h after the procedure, with a decrease of hemoglobin level from 10.9 to 7.8 g/dl; however, he responded to normal saline infusion and blood transfusion.The cause of the bleeding was thought to be a burn effect of cautery dilator.A nasogastric tube was placed to monitor the bleeding, and spontaneous hemostasis was achieved without the need for endoscopic procedures.In other patients in whom bleeding occurred during the procedure, immediately, after puncture with a 19g needle, eus doppler mode displayed bleeding on the surface of the liver, and the procedure was withdrawn.The reason for the bleeding was thought to be puncture of a blood vessel by the 19g needle.However, there were no change in vital signs nor hematemesis, and eus-hes was successfully performed 1 week later.One patient with cholecystitis required percutaneous drainage 2 days after the procedure.The other seven patients were treated by conservative therapy, including antibiotics.There were no intervention-associated deaths.The results demonstrated that for patients with benign pancreaticobiliary diseases in whom conventional ercp was unsuccessful, eus-hes using a dedicated plastic stent was safe and feasible.Type of adverse events/number of patients: eus-hgs, peritonitis (bile juice leakage) - 4 patients, bleeding - 2 patients, cholecystitis - 2 patients, pneumoperitoneum - 1 patient, cholangitis - 1 patient.This article includes 6 reports as follows: (b)(6) all ae, na-u200h-8019.(b)(6) all ae, gf-uct260.(b)(6) patient 2 with cholecystitis, na-u200h-8019.(b)(6) patient 2 with cholecystitis, gf-uct260.(b)(6) patient 3 with bleeding, na-u200h-8019.(b)(6) patient 3 with bleeding, gf-uct260.This report is 3 of 6 for (b)(6) patient 2 with cholecystitis, na-u200h-8019.
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
Additional information received from the author: in the medical opinion of the author, the olympus devices did not cause or contribute to the adverse events described in this literature.The author stated there was no olympus device malfunction.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information from the legal manufacturer's final investigation and author.New information was added to the following fields: b5, h6, h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.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): 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: 14757121
• Report Number: 8010047-2022-10450
• Device Sequence Number: 14958045
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: 04953170380402
• 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): 07/18/2022

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-8019
• 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: 05/22/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/18/2022
• 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: MULTIPLE NON-OLYMPUS DEVICES.; UNK: GF-UCT260, G-260-2545A.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male