Adverse Events during surgery and in the postoperative course up to 6 months | Number of subjects n (%) | Number of events n | Full recovery with intact treatment effect |
---|---|---|---|
Number of Adverse Events (n = 50) | 8 (16%) | 11 | YES |
Device related adverse events (SADE or ADE) | 0 | 0 | |
Surgical non-device related serious adverse events (SAE) | 4 (8%) | 6 | YES |
Severe | |||
Mediastinal abscess, empyema and abdominal abscess | 1a | 3 | YES |
Intra-abdominal haemorrhage | 1 | 1 | YES |
Moderate | |||
Pleuritis | 1 | 1 | YES |
Mild | |||
Removal of foreign body (part of a needle from the abdominal wall) | 1 | 1 | YES |
Surgical non-device related non-serious adverse events (AE) | 4 (8%) | 5 | YES |
Moderate | |||
Abdominal pain and incisional hernia | 1b | 2 | YES |
Mild | |||
Accidental intra-operative instrumental hepatic lesion (small) | 1 | 1 | YES |
Post-op delayed gastro-intestinal paralysis (one day) | 1 | 1 | YES |
Procedural pneumothorax | 1 | 1 | YES |
Adverse Events between 6 months and 1 yearc | 1 (2%) | 1 | YES |
Device related adverse events (SADE or ADE) | 0 | 0 | |
Surgical non-device related serious adverse events (SAE) | 1 (2%) | 1 | YES |
Moderate | |||
Release of fundoplication sutures – successfully re-sutured | 1 | 1 | YES |