COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
|
Back to Search Results |
|
Catalog Number NTSE-022115-UDH |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/26/2023 |
Event Type
malfunction
|
Event Description
|
As reported, during a transurethral urolithotomy, an ncircle tipless stone extractor was tested in an uncoiled position prior to use but did not open completely.The procedure was completed using another same device.The returned device was kept in its original condition.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
|
|
Manufacturer Narrative
|
E1: customer phone = (b)(6).E1: customer postal code = (b)(6).G4: pma/510(k) number = exempt.H3: device evaluated by mfg = other (code unspecified, describe in h10: (81) = device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.
|
|
Search Alerts/Recalls
|
|
|