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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST TRADITION L FIBER OPTIC; AIR-POWERED DENTAL HANDPIECE

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DENTSPLY PROFESSIONAL MIDWEST TRADITION L FIBER OPTIC; AIR-POWERED DENTAL HANDPIECE Back to Search Results
Catalog Number 780045
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
In this event it was reported that a cap came off from a tradition handpiece during a procedure.The reported complaint did not result in an injury or need for intervention.
 
Manufacturer Narrative
Though medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Initial observations supported the reported complaint.Production & quality testing of the handpiece was not performed as the device came in missing a cartridge.Multiple dimensions on the head and cap were checked by production personnel.Dentsply is unable to determine how the cap might have come unscrewed as all handpieces are 100% performance tested prior to shipping.
 
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Brand Name
MIDWEST TRADITION L FIBER OPTIC
Type of Device
AIR-POWERED DENTAL HANDPIECE
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
des plaines IL
Manufacturer Contact
helen lewis
221 w. philadelphia st
ste 60
york, PA 17401
7178457511
MDR Report Key4641586
MDR Text Key5602926
Report Number1419322-2015-00017
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 02/24/2015
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 Catalogue Number780045
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/28/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/24/2015
Initial Date FDA Received03/25/2015
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 Unknown
Patient Sequence Number1
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