Adverse events associated with the gold probe and the injection gold probe devices used for endoscopic hemostasis: A MAUDE database analysis

Table 1 Reported procedure type in which gold probe was used

Procedure	Number
Bronchoscopy	7
Colonoscopy	25
Esophagogastroduodenoscopy	47
Enteroscopy	3
Endoscopic retrograde cholangiopancreatography	6
Missing	52
Total	140

Table 2 Reported procedure type in which injection gold probe was used

Procedure	Number
EGD	174
Colonoscopy	16
ERCP	11
Enteroscopy	1
Total	202

EGD: Esophagogastroduodenoscopy; ERCP: Endoscopic retrograde cholangiopancreatography.

Table 3 Failure Modes of gold probe (Primary Outcomes)

Failure mode	Number	Percentage
Arcing	1	0.7
Component missing	1	0.7
Detachment of device component	1	0.7
Electrical connector broke during use	1	0.7
Failure to deliver energy	107	76.4
Material separation	28	20.0
Tip bent (from packaging)	1	0.7
Total	140	100.0

Table 4 Failure modes of injection gold probe (Primary Outcomes)

Failure mode	Number	Percentage
Crack	9	4.5
Material separation	34	16.8
Device detachment	27	13.4
Failure to deliver energy	115	56.9
Material puncture/hole	5	2.5
Mechanical problem	12	5.9
Total	202	100.0

Table 5 Events affecting patients with gold probe failure (Secondary Outcomes)

Events	Number
Bowel burn	1
Hemorrhage/Bleeding	1
Prolonged hospital stay	1
Removal requiring a second procedure	7
Total	10

Table 6 Events affecting patients or equipment with injection gold probe failure (Secondary Outcomes)

Events	Number
Prolonged hemorrhage	2
The secondary procedure to retrieve the detached probe	48
Probe damaged scope	3
Total	53

Table 7 Reports by year (2013-2023)

Year	MAUDE reports for gold probe	MAUDE reports for injection gold probe
2013	32	38
2014	32	36
2015	17	33
2016	26	30
2017	14	23
2018	3	6
2019	3	9
2020	2	8
2021	4	7
2022	1	5
2023	6	7
Total	140	202

MAUDE: Manufacturer and User Facility Device Experience.