Intraoperative Mechanical (Structural) Failure of a Phacoemulsification Probe

1
Intraoperative Mechanical (Structural) Failure of
a Phacoemulsification Probe

• Rachel E. Peck, MD
• Herbert J. Ingraham, MD
• Geisinger Medical Center, Department of
  Ophthalmology
• Danville, PA

No financial interest
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PURPOSE

• To report a case in which the distal 4 mm tip of
  a reprocessed flared 30 degree 1.1mm
  phacoemulsification probe broke off from its base
  intraoperatively.

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CASE PRESENTATION

• Our case was a routine cataract surgery, in which
  a superior scleral tunnel approach was used.
• Within seconds of the initiation of
  phacoemulsification, the tip spontaneously broke
  off.
• Phacoemulsification was immediately stopped and
  the phaco probe and broken tip were both safely
  removed from the eye.

4
The reprocessed phacoemulsification probe that
broke intraoperatively
A similar flared 30 degree 1.1mm
phacoemulsification probe
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Enlarged photo showing the jagged edges of the
complete detachment of the tip of the probe from
its base.
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REPROCESSED SINGLE USE DEVICES

• Phacoemulsification probes are typically marketed
  as single use devices (SUDs) that the original
  equipment manufacturers (OEMs) have not validated
  for repeated use.
• However, due to both economic and environmental
  advantages, many hospitals and ambulatory surgery
  centers have adopted policies that allow the use
  of SUDs that have been reprocessed by third
  parties or hospitals.
• The FDA monitors the use of reprocessed SUDs, and
  believes that reprocessed SUDs that meet the
  FDAs regulatory requirements are as safe and
  effective as a new device. 1

1 Statement of Daniel Schultz, MD, Director CDRH,
Before the Committee on Governmental Reform-Sept
26 2006. www.fda.gov
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CONCLUSION

• This case raises the question of the frequency of
  mechanical failure of reprocessed
  phacoemulsification instruments and whether
  repeated use of the probe can result in
  structural weakness due to reprocessing and/or
  oscillatory power.
• Reprocessing surgical instruments has economic
  and environmental benefits, however this must be
  balanced with safety and the ability of the
  phacoemulsification probe to undergo repeated
  use.
• This is the only incidence of a reprocessed
  phacoemulsification instrument breaking
  intraoperatively that we are aware of. Perhaps
  it is a rare, random occurrence, or it could be
  an under-reported phenomenon. Further discussion
  is warranted.