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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ALLIGATOR TOOTH RETRIEVAL FORCEPS FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC ALLIGATOR TOOTH RETRIEVAL FORCEPS FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Investigation - evaluation: a review of documentation, manufacturing instructions, and specifications was conducted during the investigation. The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed. Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event. Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping. Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident. No lot number was provided; therefore a review of non-conformances or associated complaints cannot be completed at this time. Based on the provided information a definitive root cause cannot be established or reported at this time. Per the risk assessment no further action is required. We will notify the appropriate personnel and continue to monitor 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 during an intended ureteroscopy, alligator tooth retrieval forceps got stuck inside the patient¿s body due to the tight ureter. Additional information was requested regarding this event, the removal of the forceps, and the patient outcome; however, no further information has been provided at this time.
 
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Brand NameALLIGATOR TOOTH RETRIEVAL FORCEPS
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 Key6590528
MDR Text Key196703781
Report Number1820334-2017-01081
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number210321
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 Received07/19/2017
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 Initial

Patient Treatment Data
Date Received: 05/25/2017 Patient Sequence Number: 1
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