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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number NTSED-024115-UDH
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2017
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged. Investigation ¿ evaluation. A review of manufacturing instructions, specifications, drawings, quality control data, and visual inspection was conducted during the investigation. The complaint device was returned for evaluation. The device was returned with the handle severed and in the open position. A visual examination noted the support sheath severed 7 mm from the proximal end. The basket sheath was kinked 7 mm from the proximal end. The support sheath and the basket sheath were still adhered. The basket formation was in a partially closed position with 7 mm extending past the distal tip of the basket sheath. A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident. Based on the provided information a definitive root cause cannot be established or reported at this time. We will notify the appropriate personnel and continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
 
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 during a ureteroscopy procedure, the ncircle delta wire tipless stone extractor made a grinding noise and the basket broke off its white handle. No adverse effects or consequences were reported to the patient due to this occurrence.
 
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Brand NameNCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7147677
MDR Text Key286334335
Report Number1820334-2017-04332
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNTSED-024115-UDH
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

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