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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA DOUBLEAIRHOSE L3M F/APD
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SYNTHES USA DOUBLEAIRHOSE L3M F/APD Back to Search Results
Catalog Number 05.001.083
Device Problems Air Leak (1008); Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2013
Event Type  malfunction  
Event Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: during an operation on (b)(6) 2013, air leaking was heard from the device in question.It was checked after the operation when the surgeon heard it pop and felt the inner hose come off.A repair was attempted, but it was found to be incapable of repair.This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was performed and no complaint related issues were found.Placeholder.
 
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Brand Name
DOUBLEAIRHOSE L3M F/APD
Manufacturer (Section D)
SYNTHES USA
west chester PA
Manufacturer Contact
w. lindenmuth
1302 wrights lane east
west chester, PA 19380
8006207025
MDR Report Key3586852
MDR Text Key17389549
Report Number2520274-2014-00278
Device Sequence Number1
Product Code HBB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K093361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05.001.083
Device Lot Number31096
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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