MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.; SINGLE USE ASPIRATION NEEDLE

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

Patient Problems Cyst(s) (1800); Hemorrhage/Bleeding (1888); Fibrosis (3167)

Event Type  Injury  

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 lot 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 was no description of the device's malfunction.

Event Description

On july 29, 2021, omsc received the literature "a case of pseudocyst formation due to pancreatic juice leakage after eus-fna for pancreatic cancer¿.The purpose of the literature was to report the formation of pseudocysts due to pancreatic juice leakage as an incidental disease of endoscopic ultrasound-fine needle aspiration (eus-fna), which is rare, with literature discussion.The procedure was performed using a 19 g needle (olympus).The literature wrote as below.¿on december 15, x-1, when he was hospitalized for bacterial pneumonia and acute renal meningitis, ct scan showed a mass in the tail of the pancreas.The pancreatic mass was a 20 mm in diameter mass with indistinct borders.It was poorly contrasted than the surrounding pancreatic parenchyma in the early stage of contrast and was contrasted almost as much as the surrounding pancreatic parenchyma in the late stage of contrast, accompanied by a dilatation of the caudal main pancreatic duct.In blood tests, cai9-9 was within the normal range, but cea 10.18 ng/ml and dupan-2 780 u/ml were found to be high.On december 22, x-1, the patient underwent endoscopic ultrasound puncture-needle aspiration (eus-fna) for histological diagnosis of the pancreatic mass.Eus showed a hypoechoic mass with indistinct borders and a heterogeneous interior at the tail of the pancreas, which was suspected to be pancreatic cancer.Two punctures were made with a 19g needle (ez shot 3 plus.Olympus) in the same area.The patient was discharged from the hospital on december 26, x-1 with no apparent intraoperative or postoperative complications.Histopathological diagnosis of adenocarcinoma was made, and the patient was diagnosed as ct2nomo stage ib (pancreatic cancer treatment code, 7th edition).Preoperative chemotherapy (tegafur, gimeracil, oteracil potassium (s-1) + cgcitabine (gem)) was started on january 4, x.Ct scan showed a 90 mm fluid accumulation between the pancreatic tail and the stomach with increased fatty tissue density and thickened wall.On january 16, he required er.Pseudocyst and infection at the same site were suspected, and antimicrobial therapy was started.Abdominal symptoms were stabilized, but chemotherapy was considered difficult.On january 26, x, a pancreaticoduodenectomy with cyst and splenectomy was performed.The patient was discharged from the hospital on february 26, x without any major postoperative problems.Histopathological examination revealed that the cyst had hemorrhage and fibrosis on its wall, but no adenocarcinoma invasion was observed.Although there was no evidence of traffic with the pancreatic duct on the wall of the cyst, eus-fna suggested that pancreatic juice leakage occurred and formed a pseudocyst.¿ based on the available information, a direct relationship between the olympus product and these complications might not be determined.However, a case required er and the additional procedure was a serious injury, and the olympus needle might be associated with the case.This is the report regarding a case of pancreatic juice leakage that occurred and formed a pseudocyst required er and the additional procedure.

• 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: 12305666
• MDR Text Key: 268360732
• Report Number: 8010047-2021-10057
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR