Model Number LF2019 |
Device Problems
Detachment Of Device Component (1104); Peeled/Delaminated (1454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a thyroidectomy procedure, the insulation tip of the device was found damaged and chipped but nothing fell into patient's cavity.The device was used to complete the procedure since the device was activated without any issue however the chipped piece was nowhere to be found.There was no patient injury.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.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.Photographic inspection found that the plastic tip fractured on one jaw.The reported condition was confirmed.From the pictures, it might be concluded that the plastic tip was broken by damage from an external force.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.The customer indicated that the broken tip did not disengage from the device into the cavity.Engineering tested unused devices and could not replicate the mechanical damage to the tip by applying various types of forces.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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Manufacturer Narrative
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Evaluation summary: post market vigilance led an investigation into the reported complaint in conjunction with engineering.One lf2019 was received for evaluation.Visual inspection revealed that the plastic tip fractured on one jaw.The device was heavily used.It appears that the plastic tip was broken by damage from an external force.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.The customer indicated that the broken tip did not disengage from the device into the cavity.Engineering tested unused devices and could not replicate the mechanical damage to the tip by applying various types of forces.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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Search Alerts/Recalls
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