COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTSE-022115-UDH |
Device Problem
Detachment Of Device Component (1104)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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Event Date 09/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
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Event Description
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The area representative reported during a ureteroscopy procedure performed on (b)(6) 2017, the ncircle tipless stone extractor was used to retrieve a stone.While in use, the basket broke off at the neck of the basket leaving the basket in the patient.A second ncircle tipless stone extractor was used and it also broke off in the same way.When the third ncircle tipless stone extractor was put into use, it did not break off however, it would not work properly and it had to be disassembled to remove it from the patient.The procedure could not be completed.The patient had to come back to have basket fragments removed and the ureteroscopy procedure completed.The basket fragments were removed using a different device.There were no adverse effects to the patient during the interventional surgery.Additional event and patient information has been requested.Three related reports have been filed to capture each of the three device malfunctions reported to occur during one procedure.Mfr.Report # 1820334-2017-03515 captures the first basket, mfr.Report # 1820334-2017-03517 captures the second basket and mfr.Report # 1820334-2017-03519 captures the third basket used in the procedure.
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Manufacturer Narrative
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Device available for evaluation changed from "no" to "yes." evaluation / investigation: a review of the drawings, manufacturing instructions, specifications, and quality control, was performed.Visual inspection and functional testing of the returned device was also conducted.Two n circle tipless stone extractor devices were returned tangled together with the handles disassembled.Basket #1, the handle was detached.The male luer lock adaptor (mlla) and collet were detached.The polyethylene terephthalate tubing (pett) was not returned.The basket sheath measured 112.7 cm.The support sheath and the basket sheath are still adhered.The basket formation was severed and not returned for evaluation.The coil assembly could be manually actuated.There is 1.5 cm of coil extending from the basket sheath.Basket #2, the device was severely tangled.The handle was detached and disassembled, the pett was not returned.The basket sheath measured 115 cm.The cannulated handle was bent 10 cm from the proximal end.The coil was stretched and tangled.The basket formation was severed and was not returned for evaluation.Both devices have the appearance that they met resistance beyond the intended design.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record could not be reviewed as the lot information was not provided.A review of complaint history could also no be performed without the complaint device lot number.Based on the provided information and the investigation evaluation, this complaint is confirmed, however a definitive root cause for the reported issue could not be determined.Measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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