Table 5.
Patient Complications Substratified by Device Malfunction and Manufacturer Review
| Device class | Device | Complication | Cause | Manufacturer review |
|---|---|---|---|---|
| TURP | Cutting loop activation/detachment | Conversion to open | Cautery automatically activated without surgeon use, leading to intraperitoneal bladder perforation and loop detachment | Not evaluated |
| TURP | Cutting loop activation/detachment | Conversion to open | Cautery activated itself without surgeon use, leading to intraperitoneal bladder perforation and loop detachment | Not evaluated |
| TURP | Cutting loop activation/detachment | Conversion to open | Cautery activated itself without surgeon use, leading to intraperitoneal bladder perforation and loop detachment | Not evaluated |
| TURP | Cutting loop detachment | Urethral injury | Detachment of cutting loop caused urethral injury | Not evaluated |
| TURP | Cutting loop detachment | Urethral injury | Detachment of cutting loop caused urethral injury | Not evaluated |
| TURP | Resectoscope detachment | Conversion to open | Unable to retrieve detached tip, intraperitoneal bladder perforation encountered while attempting to remove tip | Misuse by user |
| TURP | Electrosurgical generator | Cutaneous burns (urethral meatus) | Device evaluated by manufacturer and found to be in good working condition. | Unknown |
| TURP | Electrosurgical generator | Cutaneous burns (urethral meatus) | Manufacturer review demonstrated an increased leakage current for the generator due to defective uninterruptible power supply | Manufacturer defect |
| TURP | Electrosurgical generator | Cutaneous burns (urethral meatus) | Device evaluated by manufacturer and found to be in good working condition. | Unknown |
| HoLEP | Morcellator dysfunction | Hemorrhage | Difficulty with morcellation and bladder perforation that required blood transfusion | Manufacturer defect |
| HoLEP | Morcellator dysfunction | Conversion to open | Difficulty with morcellating tissue and resulting intraperitoneal bladder perforation requiring open repair | Manufacturer defect |
| HoLEP | Morcellator dysfunction | Conversion to open | Unable to morcellate tissue, required conversion to open to remove adenoma | Not evaluated |
| HoLEP | Morcellator dysfunction | Conversion to open | Unable to morcellate tissue, required conversion to open to remove adenoma | Not evaluated |
| HoLEP | Morcellator dysfunction | ICU admission | Difficulty with morcellation and bladder perforation that required ICU stay | Manufacturer defect |
| GreenLight™ | End-firing laser fiber | Extraperitoneal bladder perforation | Excessive heat accumulation causing bladder perforation | Misuse by user |
| GreenLight™ | End-firing laser fiber | Extraperitoneal bladder perforation | Excessive heat accumulation causing bladder perforation | Misuse by user |
| UroLift® | Needle breakage | Second procedure | Needle broke off during device use, required second procedure to remove when recognized | Misuse by user |
| UroLift® | Needle breakage | Hemorrhage | Needle broke off during device use, patient had significant bleeding that required blood transfusion | Not evaluated |