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

Model Number	NA-201SX-4022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Fever (1858)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "evaluation of the safety and efficacy of minimal endoscopic sphincterotomy followed by papillary balloon dilation for the removal of common bile duct stones".The literature reported the result of 435 patients with mediastinal and hilar lymphadenopathy who underwent endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) procedure using the olympus na-201sx-4022 from may 2010 to july 2012.In the literature, it was reported complication as follows; fever after ebus-tbna (110 cases).Blood culture samples positive (2 cases): the identified organism was normal flora of the skin and there was no true bacteremia.Pneumonia (2 cases).Mediastinal abscess (1 case): a (b)(6) female patient with underlying diabetes mellitus developed fever 3 days after the procedure, at which time she was diagnosed with mediastinal abscess.After 7 days of antibiotic therapy, the patient became afebrile.The patient was successfully treated with antibiotics for 6 weeks.Omsc assumes that the mediastinal abscess was a serious injury due to the required 7days of antibiotic therapy.There are not mentioned that these complications were related to the subject device in question.However, omsc assumes that "mediastinal abscess" might be related to "na-201sx-4022" due to the procedure using "na-201sx-4022".Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.Therefore, omsc assumes that the "mediastinal abscess" was adverse events to submit due to the required 7days of antibiotic therapy.Omsc will submit a medical device report (mdr) of the subject device for the "mediastinal abscess".

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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
• MDR Report Key: 12286210
• Report Number: 8010047-2021-09886
• Device Sequence Number: 14633957
• Product Code: FCG
• UDI-Device Identifier: 04953170180972
• UDI-Public: 04953170180972
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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
• Operator of Device: No Information
• Device Model Number: NA-201SX-4022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR