This report is 1 of 8 for tube (cev649-5b), which is linked to mfg report numbers: 2523190-2021-00211, 2523190-2021-00213, 2523190-2021-00214, 2523190-2021-00215, 2523190-2021-00216, 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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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.The forceps 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: evaluation of the tube was unable to conclusively verify the complaint as valid.Therefore, an investigation for cause was unable to be performed.The tube was bent and doesn't pass the electrical test.There was a hole observed in the sheath.These defects are not in relation with the reported event.According to the customer, device injured the patient when it was in contact with the small intestine.The tube is not in contact with the small intestine.Root cause: it was determined that 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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