WILSON-COOK MEDICAL INC INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; PKL, LIGATOR, HEMORRHOIDAL
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Model Number G58010 |
Device Problems
Separation Failure (2547); Failure to Fire (2610)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2023 |
Event Type
malfunction
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Event Description
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During a colonoscopy, the physician used a cook instinct plus endoscopic clipping device.It was reported that, once attached to tissue, the clip would not deploy.Nurse had to really shake catheter to get clip to release and it eventually deployed.Photos of the device being used during the procedure were provided.The photos show that the device also [moved in a tromboning manner].A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Pma/510(k): k212323 investigation evaluation: a product evaluation was performed only by the photos provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the statements and photos describing the event.The photos provided show the progression through the procedure and the clip being used in the gi tract.The photos show the distal end of the device, with the clip attached to the tissue but not yet deployed, and the clip housing has detached from the cath attach but is still connected to the drive wire.Other photos show the clip eventually deployed onto the site, which aligns with the customer's report of the clip deploying once the catheter was shaken.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: our evaluation of the photos provided confirmed the report.However, 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 states, "note: if separation of clip is not immediate, gently move catheter back and forth or use other endoscopic maneuvers to separate catheter from clip." prior to distribution, all instinct plus endoscopic clipping devices are subjected to a visual inspection and functional testing 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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