PMID- 38316225
OWN - NLM
STAT- Publisher
LR  - 20240205
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
DP  - 2024 Feb 3
TI  - Adverse Events of the Single Operator Cholangioscopy System: A MAUDE Database 
      Analysis.
LID - S0016-5107(24)00087-7 [pii]
LID - 10.1016/j.gie.2024.01.043 [doi]
AB  - BACKGROUND AND AIMS: SpyGlass single operator cholangioscopy (SOC) system is 
      generally considered safe but adds additional risks to those associated with 
      standard endoscopic retrograde cholangiopancreatography. METHODS: We evaluated 
      adverse events (AEs) with the SpyGlass System reported in the United States Food 
      and Drug Administration (FDA) Manufacturer and User Facility Device Experience 
      (MAUDE) database between January 2016 & August 2023. RESULTS: A total of 2331 
      device problems (SpyGlass DS:1301, SpyGlass DS II:1010) were reported. An optical 
      problem was the most reported issue with 83 for the SpyGlass DS and 457 for the 
      SpyGlass DS II. Patient related events were found in 62 (3.5%) of 1743 reports: 
      33 with SpyGlass DS, and 29 with SpyGlass DSII. The most common AEs were 
      bleeding/hemorrhage followed by perforation, infection, fever, or sepsis and 
      pancreatitis. CONCLUSIONS: Our findings add to the existing literature and 
      provides a fuller picture of potential problems associated with SpyGlass SOC.
CI  - Copyright (c) 2024 American Society for Gastrointestinal Endoscopy. Published by 
      Elsevier Inc. All rights reserved.
FAU - Chandan, Saurabh
AU  - Chandan S
AD  - Division of Gastroenterology & Hepatology, Creighton University School of 
      Medicine, Omaha, NE, USA. Electronic address: saurabhchandan@gmail.com.
FAU - Ramai, Daryl
AU  - Ramai D
AD  - Division of Gastroenterology, Hepatology, and Nutrition, University of Utah 
      Health, Salt Lake City, UT, USA.
FAU - Mozell, Daniel
AU  - Mozell D
AD  - Department of Internal Medicine, Icahn School of Medicine at Mount Sinai (NYC 
      Health and Hospitals/Elmhurst), Elmhurst, NY, USA.
FAU - Facciorusso, Antonio
AU  - Facciorusso A
AD  - Section of Gastroenterology, Department of Medical Sciences, University of 
      Foggia, Foggia, Italy.
FAU - Diehl, David L
AU  - Diehl DL
AD  - Division of Gastroenterology and Hepatology, Geisinger Medical Center, Danville, 
      PA, USA.
FAU - Kochhar, Gursimran S
AU  - Kochhar GS
AD  - Division of Gastroenterology, Hepatology & Nutrition, Allegheny Health Network, 
      Pittsburgh, PA, USA.
LA  - eng
PT  - Journal Article
DEP - 20240203
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
SB  - IM
EDAT- 2024/02/06 00:42
MHDA- 2024/02/06 00:42
CRDT- 2024/02/05 19:22
PHST- 2023/12/07 00:00 [received]
PHST- 2024/01/09 00:00 [revised]
PHST- 2024/01/25 00:00 [accepted]
PHST- 2024/02/06 00:42 [medline]
PHST- 2024/02/06 00:42 [pubmed]
PHST- 2024/02/05 19:22 [entrez]
AID - S0016-5107(24)00087-7 [pii]
AID - 10.1016/j.gie.2024.01.043 [doi]
PST - aheadofprint
SO  - Gastrointest Endosc. 2024 Feb 3:S0016-5107(24)00087-7. doi: 
      10.1016/j.gie.2024.01.043.