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Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and voice prosthesis placement.

The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses.

Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device …