According to the reporter, during a hysterectomy procedure, insulation on the jaws fell off.It fully detached from the device and fell into patient's cavity but was retrieved.The issue occurred while sealing a vessel grasped by forceps on both sides.A new device was opened to continue.There was no patient harm.
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Evaluation summary: one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received because of the broken tip of the jaw.Visual inspection found that the plastic tip fractured on one jaw.The broken piece was returned.There was mechanical damage (e.G., scratching) on the jaw plate.The device was used with a lot of eschar.The reported condition of disengaging into cavity could not be confirmed.Component disengaging and insulation damage could be confirmed.The device was investigated with the help of engineering who concluded that the plastic tip was broken by damage from an external force.Scratching on the jaw plate indicates damaging contact with a hard object (e.G., a tool).Manufacturing and supplier were ruled out as the cause of the fracture by the engineering.The exact cause of the damage could not be determined.Engineering tested unused devices and could not replicate the mechanical damage to the tip by applying various types of forces.The device's mechanical function, jaw gap, and closed circuit resistance were all evaluated and found to be within specification.The device was plugged into a generator and was recognized.The device was activated ten times on a saline soaked towel with satisfactory results.The investigation could not determine the root cause of the customer complaint.If information is provided in the future, a supplemental report will be issued.
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