Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYLINDER HOSE
  • 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
 

SHIRAKAWA OLYMPUS CO., LTD. CYLINDER HOSE Back to Search Results
Model Number MAJ-1080
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported, the cylinder hose experienced gas leakage.The issue occurred during an unspecified therapeutic procedure.There was no reported delay.The procedure was completed using a similar device.There was no patient harm or consequence reported as a result of this event.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CYLINDER HOSE
Type of Device
CYLINDER HOSE
Manufacturer (Section D)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
Manufacturer (Section G)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA   961-8061
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18925376
MDR Text Key337925649
Report Number3002808148-2024-02528
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170140310
UDI-Public04953170140310
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K014166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMAJ-1080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/03/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-