COOK INC COOK CERVICAL RIPENING BALLOON W/STYLET; PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
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Catalog Number J-CRBS-184000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Laceration(s) (1946)
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Event Type
malfunction
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Event Description
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It was reported that during an unspecified procedure in which the cook cervical ripening balloon with stylet was used, the patient experienced cervical lacerations that required repair.No device malfunction was reported.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.
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Manufacturer Narrative
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Device evaluated by mfr: it is unknown if the device will be returned.Occupation: perinatal safety specialist.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Event summary: it was reported that during an unspecified procedure in which the cook cervical ripening balloon with stylet was used, the patient experienced cervical lacerations that required repair.No device malfunction was reported.Investigation - evaluation: reviews of the instructions for use and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.As no lot information was received, reviews of the device history record and complaint history could not be performed.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The device is provided with instructions for use which state, "the cook cervical ripening balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction." the ifu lists "any contraindication to labor induction" as a contraindication for the device and cervical laceration and bleeding as potential adverse events.Based on the available information, cook has concluded that the most probable cause for this event could not be determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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