MAUDE Adverse Event Report: COOK INC UNKNOWN; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation (2001)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

Age/date of birth) information not provided.Sex) information not provided.Brand name) information not provided.Expiration date unknown as lot is unknown.Udi #: unknown as lot is unknown.Approx.Age of device) unknown as lot is unknown.(b)(4).Device manufacture date) unknown as lot is unknown.The event is currently under investigation.

Event Description

Very limited information has been provided, stating only that the ureter was perforated.Additional information was requested on 09 may 2016 and 12 may 2016.The sales representative advised on 12 may 2016 that no further information will be provided by the customer.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation a review of the device history record, quality control, and specifications was conducted during the investigation.The device was not returned for evaluation.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, and the results of the investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• Brand Name: UNKNOWN
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• 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: 5688418
• MDR Text Key: 46188113
• Report Number: 1820334-2016-00399
• Device Sequence Number: 1
• Product Code: GBL
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2016
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other