inhealth Blom-Singer Instructions For Use Manual page 6

bleeding, and/or spinal complications.
A secondary tracheoesophageal procedure is only recommended
with use of a rigid esophagoscope to allow for adequate
visualization of the tracheoesophageal wall and to provide
protection of the posterior esophagus. Do not use the pharynx
protector for secondary tracheoesophageal puncture. The
physician must puncture the posterior esophagoscope to prevent
puncturing into the esophagus which could result in dysphagia,
bleeding, and/or spinal complications.
If the sheath (stent) is not kept within the puncture tract after
the trocar is removed, the puncture tract may close and another
puncture operation may be warranted.
Once the puncture is completed using the device and the
indwelling voice prosthesis is placed, the individual should be
monitored closely.
Do not use this device if the package is opened or in any way
damaged. Use of a device that is not sterile may cause infection.
In addition, this device is for single-use only. Should it be reused,
there is a risk of infection due to microbial contamination. Do not
resterilize the product. Reprocessing and/or resterilization of the
device may alter its performance and device failure may occur.
If there are tears, cracks, or structural damage to the device,
discontinue use.
Caution:
COMPLICATIONS
Although rare, the following complications have been identified
to occur with tracheoesophageal puncture and therefore are
potential complications with the use of the Blom-Singer® Voice
Prosthesis Placement Surgical Kit. They include:
• aberrant perforation of the posterior esophagus with
subsequent mediastinal infection or abscess;
• peristomal infection or cellulitis, which may be prevented by
appropriate use of prophylactic antibiotics;
• aspiration around the indwelling voice prosthesis positioned
in the tracheoesophageal puncture.
6 | 37757-05C
Federal (USA) law restricts this device to sale by
or on the order of a physician.