Benign Prostatic Hyperplasia: Surgical Therapy & New Technology IIIPD64-04 DEVICE MALFUNCTIONS AND COMPLICATIONS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) SURGERY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE
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INTRODUCTION AND OBJECTIVES
Minimally invasive therapies for benign prostatic hyperplasia (BPH) should ideally decrease patient complications while maintaining benefits. We sought to investigate contemporary BPH treatment devices and their adverse events using a standardized classification system to help physicians select a modality that is associated with minimal harm.
METHODS
The MAUDE database was queried from January 2015 to September 2017 using the following terms: "Transurethral resection of prostate (TURP), Holmium Laser Enucleation of the Prostate (HOLEP), and Urolift." All devices were evaluated for malfunction, patient complications, and manufacturer review. A novel MAUDE classification system was used to standardize complications. Univariable analysis was utilized to identify a relationship between the BPH devices and serious adverse events.
RESULTS
A total of 243 reports were identified: TURP 188 (77.4%), HOLEP 39 (16.0%), and Urolift 16 (6.58%). The most common deviation included cutting loop detachment during TURP 116 (61.7%), morcellator dysfunction for HOLEP 23 (69.7%), and failure to deploy during Urolift 10 (62.5%). Total complications for all modalities included conversion to open 6 (42.9%), cutaneous burns 3 (21.4%), and urethral injury 2 (14.3%). Approximately 229 (94.2%) patients experienced no complications (MAUDE I), while 14
CONCLUSIONS
Use of TURP, HOLEP, and Urolift have minimal patient harm with over 90% of patients experiencing no complication when a device malfunction has occurred. Furthermore, manufacturer review reveals that over 40% of cases are due to misuse by the user. Urologists should select the modalities they are most comfortable with and well trained in to decrease patient harm and prevent device malfunctions.
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