It was reported, during a ureteroscopy with biopsy in the ureter/collecting system that two cup biopsy forceps were used.Both devices broke in half at the cup portion.The broken piece from one of the devices was able to be retrieved, but the broken piece from the other device was not able to be retrieved and was left in the patient.This report will be for the device where they were unable to retrieve the broken piece.Reference patient identifier (b)(6) for the device where they were able to retrieve the broken piece.No additional patient consequences were reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
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Investigation ¿ evaluation.A user facility informed cook on 02/04/2020 of an incident involving a cup biopsy forceps.The device reportedly broke in half at the cup portion during a ureteroscopy and biopsy procedure on (b)(6) 2020.Further communication with the user facility clarified that two devices were used during the procedure and both broke in half at the cup portion.A second complaint was opened for the second device since the two devices did not have the same lot number (1820334-2020-00441).The procedure was not completed as result of the device issues.One of the two broken cups remained in the patient.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, quality control data, and specifications.One device was returned for investigation.Inspection of the returned device noted the device measured 116 cm.One of the cups of the device was broken and separated.The separated cup was not returned for investigation.The device broke at the base of the cup.Functional testing of the device noted that the handle was able to actuate the remaining cup.A review of the device history record found one non-conformance related to the reported failure mode.The non-conformance was found and discarded during the manufacturing process.The manufacturing process for the biopsy devices is individual in nature and the single non-conformance was not indicative of a possible issue the remaining devices in the lot.Cook concluded that the remaining non-conformances were not related to this incident.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: important: excessive force could damage device.Store in a dark, cool, dry place.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have one cup broken off from the device.The cup was broken at the base.Two devices broke in the same manner during the same case, with the two devices being from different lots.This could indicate that there was an issue with the biopsy sample or other procedural issue that caused the breakage.The biopsy sample may have been dense enough to cause the breakage of the jaws before a sample could be obtained.There is not enough evidence to definitely conclude that the cause was procedure related, so the investigation conclusion is that the cause for the breakage could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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