DEVICE RELATED PROBLEMS AND PATIENT-RELATED ADVERSE EVENTS WITH SPYGLASS CHOLANGIOSCOPE: A MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE ANALYSIS

Aims The spyglass cholangioscope system has been available for over a decade and is used to diagnose and treat many pancreaticobiliary problems. Its safety and efficacy have been proven in many studies. However, limited data is available regarding the specific device-related problems and patient-related adverse events. We aimed at analyzing the device-related problems and patient-related adverse events with the spyglass cholangioscope system reported to the MAUDE database in the last decade.

Methods The reports from March 2011 till November 2021 were collected using the search terms “spyglass”, “spyscope”, and “spybite”

Results 1623 problems were reported in the MAUDE database in 1612 patients. The highest events were reported in the year 2018 (n=639, 39.64%). Device related events happened in 96.84% (n=1561), patient-related injury in 2.98% (n=48) and mortality in 0.19% (n=3). Device-related problems reported were material protrusion/extrusion (n=1052; 65.26%) and optical problem/low quality (n=285; 17.68%). ([Figure 1]) More than one device-related issue was reported in 8.25% (n=133) cases. The number of problems with respect to the type of device was depicted in [Table 1]. These device-related issues didn't cause any patient-related injuries in the majority (n=1554; 95.75%). Perforation (n=22, 1.36%), haemorrhage (n=17, 1.05%), infection/inflammation (n=12, 0.74%), air embolism (n=5, 0.31%), and pancreatitis (n=2, 0.12%) were the complications reported.

Table 1

TYPE OF DEVICE	n (%)	TYPE OF DEVICE	n (%)
Spyscope DS	1272 (78.91%	Spybite	12 (0.74%)
Spyscope DS II	253 (15.69%)	Spyglass Retrieval Basket	9 (0.56%)
Spyglass Direct Visualization System	35 (2.17%)	Spyglass Discover Digital Catheter	6 (0.37%)
Spyglass DS Digital Controller	17 (1.05%)	spyglass retrieval snare and miscellaneous	3 (0.19%) and 5 (0.31%)

Fig. 1

Conclusions Spyglass cholangioscope system is highly effective and safe. Patient-related injuries were minimal and rarely cause mortality. Material protrusion/extrusion and optical problem/low quality were the predominant device-related problems. Continuous innovations and improvements are required to reduce device-related issues.

Publication History

Article published online:
14 April 2022