Catalog Number CEV649-5B |
Device Problem
Electrical Shorting (2926)
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Patient Problems
Hemorrhage/Bleeding (1888); Bowel Perforation (2668); Unspecified Gastrointestinal Problem (4491)
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Event Date 09/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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This report is 6 of 8 for tube (cev649-5b), which is linked to mfg report numbers: 2523190-2021-00212, 2523190-2021-00211, 2523190-2021-00213, 2523190-2021-00214, 2523190-2021-00215, 2523190-2021-00217, and 2523190-2021-00218.A facility reported that the forcep (with components tube, insert and handle) injured a patient when it came in contact with the small intestine.The event led to an unspecified increase of surgery time.No further information has been provided.The customer returned 12 device components, as it is unknown which device was used in this event.We are awaiting further information.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: h6 (impact code).Corrected fields: h6 (clinical code).Additional information was received on 11-october-2021: during bypass surgery, the four laparoscopy forceps injured the patient as soon as they were in contact with him.They led to some bleeding during the use on small intestine and one of them pierced the small intestine.The increase of surgery time was more than 30 minutes.No information was provided on the status of the patient now.The tube (cev649-5b) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure was observed.Failure analysis: the evaluation of the tube was unable to conclusively verify the complaint reported by the customer as valid.Therefore, an investigation for cause was unable to be performed.During evaluation, the tube was observed to be bent and doesn't pass the electrical test.The threading was broken.These defects are not in relation with the reported event.According to the customer, the device injured the patient when it was in contact with the small intestine.However, the tube was not in contact with the small intestine.Root cause analysis: the investigation did not highlight any defect in relation with the reported event.Thus, this complaint is unconfirmed.The defects on the device are due to a bad handling during the storage or the reprocessing.
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Search Alerts/Recalls
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