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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTMATIC PROPHY S33; DENTAL HANDPIECE

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KAVO DENTAL GMBH SMARTMATIC PROPHY S33; DENTAL HANDPIECE Back to Search Results
Model Number SMARTMATIC PROPHY S33
Device Problems Use of Device Problem (1670); Dent in Material (2526); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/15/2024
Event Type  malfunction  
Event Description
During the palatally polishing of the teeth, the insert with the polishing attachment came loose and fell into the patient's throat, whereupon he swallowed it.An x-ray of the thorax was taken for clarification.No further medical intervention was needed.
 
Manufacturer Narrative
The product was delivered without the gear insert which fell into patients mouth, hence a testrun was not possible.This insert is normally screwed into the instruments head and locked by a defined torque.However the visual inspection showed that the head had several dents and nicks around the location where the insert should be placed.This shows that the instrument received several hits from external, e.G.Dropping during reprocessing.Such hits cause that the insert gets unlocked.If the instrument is then used further, the insert can be unscrewed further and further until it finally falls out, which was obviously the case here.A repair history cannot be provided by the user, which in the worst case means that the product has been in use for 4.5 years without being checked / repaired in a certified workshop.To avoid such incidents the instruction for use contains already several warnings, notes and instruction how to maintain and prepare the product prior to each use: 2.2 technical condition a damaged device or components could injure patients, users and third parties.>> only operate devices or components if they are undamaged on the outside.>> check that the device is working properly and is in satisfactory condition before each use.>> have parts with sites of breakage or surface changes checked by the service.>> if the following defects occur, stop working and have the service personnel carry out repair work: - malfunctions - damage - irregular running noise - excessive vibration - overheating - tool is not seated firmly in the handpiece.2.5 service and repair repairs, servicing and safety checks may only be performed by trained service personnel.Observe all the following items during servicing work: >> have the service and testing tasks carried out according to the medical product operator ordinance.>> following expiry of the warranty, have the tool holding system checked once a year.>> kavo recommends specifying in-house service intervals where the medical device is brought to a professional shop for cleaning, servicing and a function check.Define the service interval depending on the frequency o use.
 
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Brand Name
SMARTMATIC PROPHY S33
Type of Device
DENTAL HANDPIECE
Manufacturer (Section D)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, 88400
GM  88400
Manufacturer (Section G)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, 88400
GM   88400
Manufacturer Contact
klaus reisenauer
bismarckring 39
biberach / riss, 88400
GM   88400
MDR Report Key19086327
MDR Text Key340599755
Report Number3003637274-2024-00010
Device Sequence Number1
Product Code EFA
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K163239
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 04/11/2024
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 NumberSMARTMATIC PROPHY S33
Device Catalogue Number1.011.6800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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