Concomitant devices: erbe electrosurgical generator.Occupation: non-healthcare professional.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.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.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.Needle knife breakage near the distal end can occur if the device is used with excessive cautery settings.The instructions for use direct the user: "before using this device, follow recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." needle knife breakage near the distal end can occur if the needle makes contact with the distal end of the endoscope during a cautery application.The instructions for use caution the user: "when applying current, ensure needle knife is completely out of endoscope.Contact of needle knife with endoscope may cause grounding, which can result in patient injury, operator injury, a broken needle knife, and/or damage to endoscope." needle knife breakage near the distal end can also occur if the product experiences limited movement of the needle knife during electrocautery application.The instructions for use state: "caution: it is essential to move needle knife while applying current." maintaining the needle knife in one position can result in breakage of the needle knife.Prior to distribution, all huibregtse needle knife papillotomes are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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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During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook huibregtse needle knife papillotome.The device fell apart and is in pieces.All the pieces were retrieved.The following additional information was received on 05/29/2019: the tip of the device fell off into patient and was retrieved with forceps.A section of the device did not remain inside the patient's body.The detached portion of the device was retrieved with forceps.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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