Catalog Number INSC-7-230-S |
Device Problem
Migration (4003)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter section: occupation: unknown.The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
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Event Description
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During a polypectomy, the physician used two (2) instinct endoscopic hemoclips.Per the user, "the clips were used to take off (remove) a polyp, but when the physician returned to the site the clips were gone." further information stated that when the clips were placed they appeared to be attached to the tissue.The polyps were removed prior to clipping.It is unknown if this occurred during the same procedure or a different procedure.Other than the deployed clips, 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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Event Description
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During a polypectomy, the physician used two (2) instinct endoscopic hemoclips.Per the user, "the clips were used to take off (remove) a polyp, but when the physician returned to the site the clips were gone." further information stated that when the clips were placed they appeared to be attached to the tissue.The polyps were removed prior to clipping.It is unknown if this occurred during the same procedure or a different procedure.Other than the deployed clips, 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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Initial reporter section: occupation - unknown.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.Prior to distribution, all instinct endoscopic hemoclips 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 remote.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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Search Alerts/Recalls
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