PMID- 26888238
OWN - NLM
STAT- MEDLINE
DCOM- 20170711
LR  - 20170713
IS  - 1998-3603 (Electronic)
IS  - 0970-9290 (Linking)
VI  - 26
IP  - 6
DP  - 2015 Nov-Dec
TI  - Adverse events associated with ultrasonic scalers: A manufacturer and user 
      facility device experience database analysis.
PG  - 598-602
LID - 10.4103/0970-9290.176923 [doi]
AB  - BACKGROUND: The present study was conducted to determine the frequency and type 
      of adverse events (AEs) associated with ultrasonic scaler reported to the Food 
      and Drug Administration manufacturer and user facility device experience (MAUDE) 
      database. MATERIALS AND METHODS: The authors reviewed the ultrasonic scaler units 
      (USU) related AEs reported to MAUDE from October 1, 1995, to September 31, 2015. 
      Analyses of details collected are presented. RESULTS: MAUDE received a total of 
      667 unique USU-related AE reports. Of 667 cases, MAUDE classified 628 instances 
      (94.2%) as malfunction 27 (4%) as injurious, 10 (1.5%) as others, and 2 (0.3%) 
      claiming the use of USU as cause of death. Of the 667 cases, 511 (76.6%) were 
      used for endodontic application, and 147 (22%) as scaler applications. In 512 
      (76.8%) instances, there was separation of the tips, posing danger to patients or 
      users, and 112 (16.8%) instances of overheating, 12 (1.8%) instances of breakage, 
      and electrical issues in 8 (1.2%) instances. These AE resulted in 19 instances of 
      thermal injury, 2 suspicious deaths, and hearing loss in 3 cases. In 4 cases, 
      patient swallowed broken parts requiring additional medical care. CONCLUSIONS: 
      Use of USU, a Class 2 device without exemption, carries a degree of risk to 
      patient's safety, if not properly used. As of today, MAUDE data is the only 
      reliable source of AE until another database or such study is carried out. 
      Certain AE that has been largely anecdotal, such as hearing loss has been 
      reported in this study. The findings from study reiterate that more in-depth 
      analysis of AE of USU is needed. Until then operator needs to take all 
      precautions to avoid AE when using USU.
FAU - Thennukonda, Rajagopal Athmarao
AU  - Thennukonda RA
AD  - Department of Dentistry, Madurai Medical College and Hospital, Madurai, Tamil 
      Nadu, India.
FAU - Natarajan, Bhavani Rekha
AU  - Natarajan BR
LA  - eng
PT  - Journal Article
PL  - India
TA  - Indian J Dent Res
JT  - Indian journal of dental research : official publication of Indian Society for 
      Dental Research
JID - 9202990
MH  - Databases, Factual
MH  - Dental Instruments/*adverse effects
MH  - Dental Scaling/*instrumentation
MH  - Humans
MH  - Ultrasonics/*instrumentation
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2016/02/19 06:00
MHDA- 2017/07/14 06:00
CRDT- 2016/02/19 06:00
PHST- 2016/02/19 06:00 [entrez]
PHST- 2016/02/19 06:00 [pubmed]
PHST- 2017/07/14 06:00 [medline]
AID - IndianJDentRes_2015_26_6_598_176923 [pii]
AID - 10.4103/0970-9290.176923 [doi]
PST - ppublish
SO  - Indian J Dent Res. 2015 Nov-Dec;26(6):598-602. doi: 10.4103/0970-9290.176923.