Trocar-associated injuries and fatalities: An analysis of 1399 reports to the FDA

Journal of Minimally Invasive Gynecology

Volumn 12, Issue 4, 2005, Pages 302-307

  Fuller, Janie ^a,b   Ashar, Binita S ^a   Carey Corrado, Julia ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^b HFZ 520 ^*  (United States)

Author keywords

Injury; Laparoscopy; MAUDE database; Trocar

Indexed keywords

ABDOMEN; AORTA INJURY; BLOOD VESSEL INJURY; CHOLECYSTECTOMY; COMPREHENSION; DATA BASE; FATALITY; FOOD AND DRUG ADMINISTRATION; FREQUENCY ANALYSIS; HEALTH SURVEY; HUMAN; INTESTINE INJURY; LAPAROSCOPIC SURGERY; LAPAROTOMY; LAW SUIT; MEDICAL INFORMATION; MEDICAL RESEARCH; PELVIS; PERITONITIS; PUNCTURE; REVIEW; RISK FACTOR; SURGICAL INJURY; SURGICAL TECHNIQUE; TROCAR;

EID: 22144491929     PISSN: 15534650     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jmig.2005.05.008     Document Type: Article

References (14)

1. Market engineering research for the U. S. market for general surgery laparoscopy access and closure instruments. Medical and Healthcare Marketplace Guide 1999. London, UK: Frost and Sullivan; 071-730-3438; Dialog File Number 767; Accession Number 523034. [Cited 2001 Oct 18]; www.dialogselect.com/ business/cgi/present.
2. A.P. MacKay, B.A. Kieke, L.M. Koonin, K. Beattie Tubal sterilization in the United States Fam Plan Persp 33 2001 161 165
3. C. Levinson Laparoscopy is easy - except for the complications a review with suggestions J Rep Med 5 1974 187 194
4. A.J. Penfield Trocar and needle injuries J.M. Phillips Laparoscopy 1977 Williams & Wilkins Publishers Baltimore, Md 236 241
5. Laparoscopic Injury Study 2000 Physician Insurers Association of America Rockville, Md www.thepiaa.org.
6. S.L. Corson, J.G. Chandler, L.W. Way Survey of laparoscopic entry injuries provoking litigation J Am Assoc Gynecol Laparosc 8 2001 341 347
7. S.B. Bhoyrul, M.A. Vierra, C.R. Nezhat Trocar injuries in laparoscopic surgery J Am Coll Surg 192 2001 677 683
8. H.T. Sharpe, M.K. Dodson, M.L. Draper, D.A. Watts, R.C. Doucette, W.W. Hurd Complications associated with optical access laparoscopic trocars Obstet Gynecol 99 2002 553 555
9. R.M. Soderstrom Bowel injury litigation after laparoscopy J Am Assoc Gynecol Laparosc 1 1993 74 77
10. R.M. Soderstrom Injuries to major blood vessels during endoscopy J Am Assoc Gynecol Laparosc 4 1997 395 398
11. Medical Devices Early Warning of Problems Is Hampered by Severe Underreporting 1986 U.S. Government Printing Office Washington, D.C GAO publication PEMD-87-1:US
12. E. Chelinsky Medical Devices Underreporting of Problems, Backlogged Systems, and Weak Statutory Support 1990 U.S. Government Printing Office Washington, D.C GAO publication T-PEMD-90-3:US
13. Trocars: new data on safety and selection. Health Devices. 2000;29:67-71.
14. L. Yin, C.M. Witten, S.M. Neidelman Letter to manufacturers of laparoscopic trocars 1996 FDA, Center for Devices and Radiological Health Rockville, Md August 23