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Catalog Number DBF-2.4SN-230SP-40-S |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps are subjected to a visual inspection and functional test to ensure proper workability corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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Event Description
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During an esophagogastroduodenoscopy (egd), the physician used a cook captura serrated forceps with spike.The user was in the duodenum taking random biopsies.The first biopsy was fine.They placed the forceps back down the endoscope, and the forceps broke when trying to open.They would not open or close.The forceps were removed, and they used another device to complete the procedure with no issues or harm to the patient.When the cook sales representative was at this facility, they gave him the device and told him this is the second forceps device that failed [see related mdr 1307905-2017-00374].The first failure occurred approximately two (2) to three (3) weeks prior and was not reported [to cook].The user involved in this procedure was out of the office at the time of the cook sales representative visit and the exact failure or further information could not be obtained [subject of this report].
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Search Alerts/Recalls
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