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

Model Number NA-U200H-8019S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

Event Description

On december 17, 2020, olympus medical systems corp.(omsc) received the literature titled "needle tract seeding and abscess associated with pancreatic fistula after endoscopic ultrasound-guided fine-needle aspiration".This study was conducted endoscopic ultrasound-guided fine-needle aspiration (eus-fna) for a (b)(6) years old woman with pancreatic ductal adenocarcinoma (pda).In the literature, it was reported that needle tract seeding with simultaneous abscess associated with pancreatic fistula occurring after eus-fna for pda.The patient presented with a fever of 38 degrees celsius and abdominal discomfort 18 days after eus-fna for pda of the pancreatic tail with a retention cyst.An abscess associated with pancreatic fistula (apf) is secondary to main pancreatic duct injury was suspected.Simultaneous needle tract seeding was also strongly suspected because the eus-fna needle was believed to penetrate the main pancreatic duct within the tumor, causing tumor cells to come into contact with the pancreatic juice which subsequently leaked out into the needle tract.Distal pancreatectomy with partial gastrectomy was performed 4 months after eus-fna.Strong adhesion between the stomach and pancreas was observed.The pancreatic body/tail, upper stomach, eusfna and eus-cd needle tract, transverse colon, left adrenal gland, and spleen was removed en bloc with curative intent due to adhesion and suspected invasion.The post-surgical course was complicated by pancreatic fistula, which was managed conservatively.She presented with vomiting 3 months later, when she was diagnosed with liver metastases, peritoneal carcinomatosis, and duodenal obstruction near the ligament of treitz.She died 9 months after the needle tract seeding and apf and 5 months after the surgery.Based on the available information, detailed information of the subject device was not provided.Omsc will submit one medical device report (mdr) for needle tract seeding with simultaneous abscess associated with pancreatic fistula occurring after eus-fna with the subject device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Type of Device: 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: 11127718
• MDR Text Key: 225470692
• Report Number: 8010047-2021-00969
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2021

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
• Device Operator: No Information
• Device Model Number: NA-U200H-8019S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 72 YR