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1700 S TAMIAMI TRL

SARASOTA, FL 34239

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, interview with clinical and administrative staff and review of clinical data provided by the facility, the facility failed to ensure there was follow through and quality assurance related to a piece of equipment.

The findings include:

1. A review of an accident/incident report on 12/30/10 revealed Patient #4 had surgery on 10/20/10. During the procedure while using a black cautery cort inserted into a Tri-generator (a laparoscopic procedure), the cord malfunctions and burnt through the insulation and cord separated from the male plug. There was enough heat generated at the fracture for small flame to appear at the junction of the cord and male plug. The flame was extinguished by the nurse anesthetist and there was no harm to the patient. The generator was removed from service and sent to bio-med. The Biomed department indicated per interview with risk management staff on 12/30/10 at 2:30 p.m., the cord used for the cautery was noted to be the issue. They imitated a program in the supply room to check the cords when being sterilized.

Review of the unscheduled repair work order for the electrosurgical device dated 10/20/10, revealed under comments, "_________ (technician's name) indicated the problem was a badly worn UFP cable. He has indicated that these reusable cables have a finite life of +/- 30 uses. He suggested that disposable cables may be a better choice as opposed to using a reusable until it fails (cable failure is not necessarily obvious)."

A cable like the one that had caused the fire was brought to the surveyors for observations. Located on the cable was a yellow label that a "G" on it. Per the instrument technician during interview on 12/30/10 at 5:00 p.m., indicated this cable is "Look over" prior to putting in the package for resterilization. She further stated the cables are reused, but they have no method for determining the number of uses each cable has.

After interview with various administrative staff, the hospital was unable to provide any staff member who could determine if there was an evaluation after the above recommendation from the outside contractor.