TABLE 2.
Adverse events
| Surgery number | AE | Days after procedure | Seriousness (AE/SAE) | CDC grade | Converted | Relatedness to device | Expectedness |
| 41 | Acute urinary tract infection | 16 | SAE | II | No | Not related | Expected |
| 43 | Vaginal bleeding | 25 | SAE | IIIb | No | Related | Expected |
| Left ureteric duplication requiring later surgery | 74 | SAE | IIIb | Not related | Expected | ||
| 63 | Breathlessness | 1 | SAE | IVa | No | Not related | Expected |
| 88 | Urinary tract infection | 15 | AE | II | No | Not related | Expected |
| Tingling sensation in both lower limbs | 25 | AE | II | Not related | Unexpected | ||
| Lower backache radiating to both lower limbs | 25 | AE | II | Not related | Expected | ||
| 103 | Burning sensation in epigastric region | 5 | AE | I | No | Not related | Expected |
| Dysuria and increased frequency of micturition | 9 | AE | II | Not related | Expected | ||
| Pain in lower abdomen | 10 | AE | I | Not related | Expected | ||
| 107 | Breathlessness | <1 | SAE | IVa | No | Not related | Expected |
| Diabetic ketoacidosis | 3 | SAE | IVa | Not related | Expected | ||
| 117 | Urinary bladder injury | Intra‐operative | SAE | NA | Conventional laparoscopy | Not related | Expected |
Abbreviations: AE, adverse event; CDC, Clavien–Dindo classification 27 ; NA, not applicable; SAE, serious adverse event.