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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN

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COOK INC UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2017
Event Type  Injury  
Manufacturer Narrative
Corrected information: changed form "no" to "yes". The user facility reported this event to the fda on july 04, 2017 under uf/import report # (b)(4). Cook medical received this report from fda on aug 08, 2017. Upon reviewing the report, no additional reportable information was found. (b)(4). Investigation ¿ evaluation (dec 07, 2017): the ncircle tipless stone extractor was not returned for evaluation and no photographs were provided. Without the complaint device, a physical investigation was not able to be completed. A review of manufacturing instructions and quality control data was conducted. 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 was not able to be performed as the device lot number was not provided. A review for additional complaints for this device lot was also not able to be completed without the device lot number. Based on the provided information a definitive root cause could not be established. Measures have been initiated to address the reported 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.
Manufacturer Narrative
(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
It was reported that while the physician was performing ureteroscopy stone extraction procedure on a patient using the ncircle stone extractor device (serial number unknown) and the physician discovered that the basket broke inside the patient¿s ureter. No unintended section of the device remained inside the patient¿s body. The patient did require an additional procedure due to this occurrence. The physician retrieved the broken portion of the device; however, it was not disclosed how or when the broken device was removed. The complainant did not report any adverse effects on the patient due to this occurrence.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key6676310
MDR Text Key256531973
Report Number1820334-2017-01539
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/29/2017 Patient Sequence Number: 1