{"description":"all adverse events, including expected/non-related events were recorded","eventGroups":[{"description":"Group of larynx cancer patients undergoing laryngectomy whereby the puncture and the placement of the voice prosthesis is done with the Provox Vega Puncture set","id":"EG000","otherNumAffected":8,"otherNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"title":"Provox Vega Puncture Set"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"In all 3 patients known significant risk factors were present that are deemed to have caused the fistula. As such, these complications are not considered related to device/procedure. Fistula occurrence rate was within previously reported ranges.","organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3}],"term":"Pharyngocutaneous Fistula"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Posterior pharyngeal wall was damaged during dilatation before the puncture took place. Non-device related.","organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Damage posterior pharyngeal wall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Puncture penetrated posterior esophageal wall because window of device used for pharynx protection (not part of subject device)could not be located by palpation or visualization. Event did not cause any harm to patient. Event is not device related.","organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Damage posterior esophageal wall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Voice prosthesis retracted while cleaning it, and was repositioned. No patient harm. Event is related to patient anatomy, not related to device/procedure.Occurred in home situation, can occur when voice prosthesis (e.g. due to edema) fits too tight.","organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Retracted voice prosthesis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Patient developed tracheitis, caused by COPD and the related use of Prednisone and inhalation medications. Patient received antibiotics and was fine. Event was unrelated to device.","organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Tracheitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Wound healing problems considered to be caused by pre-existing risk factors (Radiotherapy,prednisone use)and surgical risk factor of bilateral neck dissection.Not device related.","organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Wound dehiscence"}],"timeFrame":"During one month after the surgery"}