MAUDE Adverse Event Report: CAREFUSION COTTLE SEPTUM SCISSORS ANG SERR 6-7/8IN; SCISSORS, NASAL

Model Number RH1701

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

Patient undergoing endoscopic frontal sinusotomy.During the surgical procedure, the end of the angled cottle spring scissor broke off into the patient's nose.The broken piece was retrieved by the surgeon and inspected to ensure all of the instrument was retrieved.  the lot number provided was "xta1", which is not a valid lot number.

Manufacturer Narrative

(b)(4).The reported issue was identified by carefusion during a review of the fda maude database for all voluntary and user facility mdr reports submitted.This complaint (b)(4) was opened by carefuson to document this reported issue.The maude report does not contain customer contact information.Therefore, carefusion cannot send notification to the customer or obtain additional information regarding the reported incident.In addition, the lot number is unknown and the actual device is not available for evaluation.Therefore, an investigation and root cause analysis cannot be performed by carefusion.The complaint will be reopened and the reported issue investigated should additional information become available.

• Brand Name: COTTLE SEPTUM SCISSORS ANG SERR 6-7/8IN
• Type of Device: SCISSORS, NASAL
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4037924
• MDR Text Key: 4803634
• Report Number: 1423507-2014-00019
• Device Sequence Number: 1
• Product Code: KBD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: RH1701
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1