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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS/SHIRAKAWA OLYMPUS CO. LTD. THUNDERBEAT AND SONIC BEAT SYSTEM; COLONOSCOPE AND ACCESSORIES
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OLYMPUS/SHIRAKAWA OLYMPUS CO. LTD. THUNDERBEAT AND SONIC BEAT SYSTEM; COLONOSCOPE AND ACCESSORIES Back to Search Results
Device Problems Corroded (1131); Moisture Damage (1405); Product Quality Problem (1506); Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 08/22/2017
Event Type  Injury  
Event Description
(b)(6) 2016 i had bought olympus thunderbeat system.On (b)(6) 2017, the sonicbeat system stopped working.Send to olympus for repair.They informed me that moisture had entered in body and part of circuit and had got rusted that is why it has happened.I had to stop laparoscopic surgeries for approximately 3 weeks.My question and worries are - how moisture or water had entered on circuit board? is there no safety feature for this in machine? this can be dangerous for patient and operating team because it can lead to short circuit.These days almost all good devices come with water and dust resistance or safe.Why they had not incorporated this feature in even this high end machine? is this a poor workmanship, poor design or poor quality of material? why not all these machines should be recalled for correction and then safely used on patients.How can we be sure that this type of problem will not occur during surgery in future.
 
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Brand Name
THUNDERBEAT AND SONIC BEAT SYSTEM
Type of Device
COLONOSCOPE AND ACCESSORIES
Manufacturer (Section D)
OLYMPUS/SHIRAKAWA OLYMPUS CO. LTD.
MDR Report Key6900057
MDR Text Key87845948
Report NumberMW5072505
Device Sequence Number1
Product Code FDF
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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