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During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook huibregtse triple lumen needle knife.
It was reported that the needle knife tip broke off and was embedded in the ampulla.
It was retrieved with a rat tooth grasper.
Our attempts to collect additional information regarding patient outcome have been unsuccessful.
While the complainant stated that the needle knife tip broke off and was embedded in the ampulla, and was retrieved with a rat tooth grasper, the information able to be collected does not reasonably suggest the patient experienced further adverse effects.
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Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.
During functional testing the handle of the device was manipulated, with the black stopper block and thumbscrew loosened.
The remaining portion of the needle knife advanced 8mm, then retracted fully.
The detached portion of the needle was also returned.
This segment of the needle measured within specification, indicating it is unlikely any other portion is missing.
A visual inspection of the needle portion that returned exhibits evidence of a cautery application (blackening of the needle was noted) and a rounded edge.
An unknown liquid within the tubing was also noted during the visual examination.
It is unknown how the portion of the needle detached from the device.
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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.
Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.
This limits our ability to conclusively determine a cause.
Needle knife breakage near the distal end can 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 cutting wire while applying current.
Maintaining cutting wire in one position may cause excessive focal coagulation, charring of tissue and/or damage to cutting wire.
" maintaining the needle knife in one position can result in breakage of the needle knife.
Needle knife breakage near the distal end can also occur if the device is used with excessive cautery settings or if the needle makes contact with the distal end of the endoscope during a cautery application.
The instructions for use direct the user: "before using this papillotome, follow the recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through the proper placement and utilization of the patient return electrode.
Ensure a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure.
When applying current, contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to endoscope.
" prior to distribution, all huibregtse triple lumen needle knives 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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