Background Single-probe dual-energy (SPDE) lithotripters were introduced to replace dual-probe dual-energy lithotripters to safely fragment and remove stones faster with a smaller footprint during PCNL. Two prominent examples are ShockPulse-SE (SE) and Swiss LithoClast® Trilogy (SWI). This study analyzes adverse events to assess safety and detect trends that may offer surgeons valuable insight for preoperative planning, counseling, and intra-operative device troubleshooting.
Methods The FDA Manufacturer and User Facility Device Experience Database (MAUDE) was retrospectively reviewed for reports from 2019 to 2022 using the keywords “shockpulse”, “lithoclast”, and “SPDE”. Duplicate and incomplete reports were excluded. The Gupta severity classification system was used to report complications and device-related causality. Pearson’s chi-square analysis compared the incidence of complications between SE and SWE. To affirm this analysis, the LexisNexis law database was also queried for all lawsuits related to SPDE lithotripters.
Results Out of the 270 reports examined, 249 met the inclusion criteria, with 235 (94.4%) involving SE and 14 (5.6%) related to SWI. SE cases were classified as malfunction (97.4%) and injury (2.6%). Analysis of event descriptions demonstrated the three most common device problems were break (54.4%), output (19.1%), and activation (6.0%). SWI events were classified as malfunction (92.9%) and injury (7.1%). The device problems were breaking (50.0%) and overheating (50.0%). 97.4% and 92.9% of SE and SWI complications, respectively, were minor (Level 1). SWI was not more likely to have major (Level 2-4) complications compared to SE [X2(1, N=249) 1.02, p>0.05]. A report of bladder perforation was seen in SE at a rate of 0.4%. No fatalities were noted. The law search yielded no SPDE-related lawsuits.
Conclusion For patients undergoing PCNLs, both SE and SWI remain safe options. However, complications do occur, though usually minor with no associated lawsuits. The lower incidence of adverse events reported for SWI compared to SE correlates with findings from a prospective multi-institutional study indicating more malfunctions with SE. Common problems including malfunction events and breaks, emphasize the importance of continuous monitoring and research in SPDE lithotripters to enhance patient safety and optimize technology efficacy.
| Single-Probe Dual-Energy Lithotripters (n=249) | |||
| ShockPulse-SE (n=235) | Swiss LithoClast® Trilogy (n=14) | ||
| Event Type | Malfunction | 229 (97.4%) | 13 (92.9%) |
| Injury | 6 (2.6%) | 1 (7.1%) | |
| Device Problem | Breaking | 128 (54.4%) | 7 (50.0%) |
| Overheating | 2 (0.9%) | 7 (50.0%) | |
| Output | 45 (19.1%) | 0 (0.0%) | |
| Connection | 13 (5.5%) | 0 (0.0%) | |
| Activation | 14 (6.0%) | 0 (0.0%) | |
| Electrical | 6 (2.6%) | 0 (0.0%) | |
| Leak/Splash | 5 (2.1%) | 0 (0.0%) | |
| Loss of Power | 5 (2.1%) | 0 (0.0%) | |
| Image Display | 3 (1.3%) | 0 (0.0%) | |
| Metal Shaving Debris | 2 (0.9%) | 0 (0.0%) | |
| Suction | 2 (0.9%) | 0 (0.0%) | |
| Other | 10 (4.3%) | 0 (0.0%) | |
| Gupta Severity Classification System | Level 1 | 229 (97.4%) | 13 (92.9%) |
| Level 2 | 3 (1.3%) | 1 (7.1%) | |
| Level 3 | 3 (1.3%) | 0 (0.0%) | |
| Level 4 | 0 (0.0%) | 0 (0.0%) | |
