Blank fields on this form indicate the information is unknown or unavailable.Customer occupation = or coordinator.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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It was reported that a universa soft ureteral stent set became encrusted and difficult to remove.The stent was originally placed (b)(6) 2022.On (b)(6) 2023, the patient returned for stent removal but the stent could not be removed due to stone encrustation at the proximal end of the stent.The patient was admitted inpatient for 2-days for a percutaneous nephrolithotomy (pcnl) nephrostomy tube placement.The patient then returned to the hospital on (b)(6) 2023 for an extracorporeal shock wave lithotripsy (eswl); the stent was not removed at this time.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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Summary of event: it was reported that a universa soft ureteral stent set became encrusted and difficult to remove.The stent was originally placed (b)(6) 2022.On (b)(6) 2023, the patient returned for stent removal but the stent could not be removed due to stone encrustation at the proximal end of the stent.The patient was admitted inpatient for 2-days for a percutaneous nephrolithotomy (pcnl) nephrostomy tube placement.The patient then returned to the hospital on (b)(6) 2023 for an extracorporeal shock wave lithotripsy (eswl); the stent was not removed at this time.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.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), quality control procedures, and personnel interviews were conducted during the investigation.The customer did not return the complaint device to cook for investigation.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.The product ifu provided the following information: precautions: ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors¿.¿ potential adverse events complications of ureteral stent placement are documented.These complications include, but are not limited to: encrustation cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The cause of the encrustation was unable to be determined with the available information.Procedural and patient factors were unable to be ruled out as potential encrustation causes.The risk analysis for this failure mode was reviewed and no additional escalation is required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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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