• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX Back to Search Results
Model Number NA-U401SX-4022
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Hypoxia (1918); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation. The investigation is ongoing. This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
Event Description
It is reported in the literature article titled ¿comparison of ultrasonic bronchoscope uc290f and uc260fw at our hospital¿; patients experienced adverse events during or after procedures using olympus devices. Case with patient identifier (b)(6) reports na-403d-2021. Case with patient identifier (b)(6) reports bf-uc260fw. Case with patient identifier (b)(6) reports bf-uc290f. Case with patient identifier (b)(6) reports na-u401sx-4022. Background: the ultrasonic bronchoscope is effective for collecting specimens of lesions in contact with the central airway, and we have introduced the ultrasonic bronchoscope uc290f since september 2020. We report this because we examined the comparison with the uc260fw that was used until then. Method: from november 2019 to november 2021, 177 cases using an ultrasonic bronchoscope were retrospectively examined at our hospital. Results: median age 71 years (24-84 years). 125 males and 52 females. Uc290f 49 cases, biopsy needle visishot2 22g 48 cases, visishot 19g 1 case, average number of biopsies 4. 1 times. Uc260fw 128 cases, biopsy needle visishot2 22g 116 cases, cook22g l 1 case, cook25g 1 case, average number of biopsies 4. 1 times. The biopsy site was uc290f lymph node lesions in # 718 cases, # 4r17 cases, # 11 6 cases, # 2r 1 case, # 4l 1 case, # 10 1 cases, # 13 1 cases, lung lesions were in 3 cases on the dorsal side of the middle trunk and 1 case on the ventral side of the left main bronchus. Lymph node lesions of uc260fw were # 760 cases, # 4r32 cases, # 11 10 cases, # 4l7 cases, # 10 6 cases, # 2r5 cases, # 2ll cases, lung lesions were found in 6 cases on the dorsal side of the middle trunk and 1 case on the left main bronchus bifurcation. The diagnosis rate is uc290f 77. 6%, uc260fw 79. 7%. Complications were uc290f with backflow during puncture in 1 case, mediastinal abscess in 1 case, arrhythmia in 1 case, uc260fw with hypoxia in 2 cases, backflow during puncture in 1 case, accidental puncture of blood vessels in 1 case, and bleeding in 1 case. Conclusion: there was no significant difference in the diagnosis rate and complications. Further cases will be collected and presented. There is no report of any olympus device malfunction reported in any procedure described in this literature.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE USE ASPIRATION NEEDLE NA-U401SX
Type of DeviceSINGLE 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 Key14642264
MDR Text Key293632024
Report Number8010047-2022-09709
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNA-U401SX-4022
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/13/2022
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 Initial

Patient Treatment Data
Date Received: 06/09/2022 Patient Sequence Number: 1
-
-