• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NGE-017115-MB
Device Problems Break (1069); Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/07/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was performed during the investigation. A review of complaint history, the device history record, documentation, quality control data and specifications was also conducted. No issues were identified that are related to the reported complaint. One device was returned for evaluation. The device was returned with the unidex (udh) handle and the basket formation in the closed position. A visual examination noted a kink at the base of the support sheath. One of the basket wires were observed to be separated and part of the wire appears to be missing. A functional test was performed and the udh handle does actuate the basket formation. Based on the investigation evaluation, 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. A review of the device history record found no non-conformances associated with the complaint device lot number that would cause or contribute to the reported failure mode of device being cracked/broken. A review of complaint history revealed this complaint to be the only reported complaint associated to the complaint lot number 6971053. Based on the provided information a definitive root cause cannot be established. 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.
 
Manufacturer Narrative
The 9. 5 fr sheath and flexible ureteroscope. (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.
 
Event Description
During a kidney stone extraction procedure the basket "broke or cracked". No pieces of the basket separated from the device. The product was replaced and the procedure continued successfully. No section of the device remained inside the patient's body. No additional procedure or adverse effects.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNGAGE NITINOL STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6730701
MDR Text Key259272822
Report Number1820334-2017-01718
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNGE-017115-MB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1820334-2017-01718

-
-