Model Number N/A |
Device Problems
Fracture (1260); Device Inoperable (1663)
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Patient Problems
Foreign Body In Patient (2687); No Information (3190); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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The warnings in the package insert state this type of event can occur.Because the lot number is unknown, the device history records could not be pulled and reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report one of two for the same event.Report two of two is reported on mfr #0001032347-2016-00593.Device not returned.
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Event Description
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It was reported that the scissors "have a chip on tip" and are not cutting properly on the first and second uses.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.This is report one of two for the same event.Report two of two is reported on mfr #0001032347-2016-00593-1.
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Event Description
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Additionally, it was confirmed that a tiny piece of the tip broke off during a procedure while the doctor was cutting the wire on an arch bar.It is reported the doctor noticed the broken tip after the wire was cut.It is reported that suction was used to try to remove the tip from the patient.However, it was not confirmed if the removal attempt was successful.It is reported that this event did not cause a delay and the doctor does not consider this a patient injury.
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Manufacturer Narrative
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The product was returned for evaluation.The product identity was confirmed in the evaluation.A visual inspection revealed moderate signs of wear including minor scratches along the length of the product, a piece of black tape wrapped around the handle, and a fracture at the very tip of the cutting blade; therefore the complaint is confirmed.The most-likely cause was determined to be excessive force applied at the tip.The non-conformance database was reviewed in the evaluation and no non-conformances were found.According to the evaluation, there are no indications of manufacturing defects.This is report one of two for the same event.Report two of two is reported on mfr #0001032347-2016-00593-1.
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Manufacturer Narrative
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Two possible lot numbers were identified for this customer.The lot numbers are 520068 (manufacture date: dec 27, 2005) and 050902 (manufacture date: sep 2, 2005).
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Search Alerts/Recalls
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