MAUDE Adverse Event Report: CAREFUSION 2200, INC. V. MUELLER ANGLED COTTLE SPRING SCISSOR; SCISSORS, NASAL

Catalog Number RH1701

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/15/2014

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.

• Brand Name: V. MUELLER ANGLED COTTLE SPRING SCISSOR
• Type of Device: SCISSORS, NASAL
• Manufacturer (Section D): CAREFUSION 2200, INC.; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 3831952
• MDR Text Key: 4401513
• Report Number: 3831952
• Device Sequence Number: 1
• Product Code: KBD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RH1701
• Device Lot Number: XTA1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2014
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 134