MAUDE Adverse Event Report: COOK INC UNKNOWN

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

(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.

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.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6676310
• MDR Text Key: 78660145
• Report Number: 1820334-2017-01539
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 12/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention