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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP SONICISION REUSABLE GENERATOR
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COVIDIEN LP SONICISION REUSABLE GENERATOR Back to Search Results
Model Number SCG
Device Problem Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
 
Event Description
The customer reported that the generator stopped working during a case.The surgical time was said to have been extended by one hour due to the surgeon having to use a monopolar instrument in order to complete the case.There was no patient injury.
 
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Brand Name
SONICISION REUSABLE GENERATOR
Type of Device
SONICISION REUSABLE GENERATOR
Manufacturer (Section D)
COVIDIEN LP
5920 longbow drive
boulder CO 80301
Manufacturer Contact
sharon murphy
5920 longbow drive
boulder, CO 80301
2034925267
MDR Report Key5034805
MDR Text Key25129658
Report Number1717344-2015-00592
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Report Date 08/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSCG
Device Catalogue NumberSCG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/27/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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