The customer reports during a transurethral resection in saline (turis) procedure using an electrical surgical unit with a foot pedal, after about an hour of use, the physician released the foot pedal, but the device did not disengage resulting in a hole in the patient¿s bladder.The operation was abandoned, and the patient was sent to recovery.The surgeon is a regular user of the equipment and does not believe this was caused by to user error.The next scheduled maintenance for the device was due (b)(6).The device has worked fine on prior procedures.The customer has requested a field service coordinator to come in and inspect the equipment.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.Case with patient identifier (b)(6) reports the electrosurgical unit used in the procedure.Case with patient identifier (b)(6) reports the foot pedal used in the procedure.
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