MAUDE Adverse Event Report: CAREFUSION 2200, INC. SNOWDEN-PENCER TEBBETTS; LIGHT CABLE

Catalog Number 88-9760

Device Problems Material Separation (1562); Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

Approximately 6 hours into an 8 hour case, the nurse was asked to take the light source out of standby.The surgeon picked up gold tip retractor which was connected to a fiber light cord draped across patient in sterile field and noticed that the fiber cord separated from the connector.Fiber strains were exposed as a result of the separation, some of which fell into open breast.

• Brand Name: SNOWDEN-PENCER TEBBETTS
• Type of Device: LIGHT CABLE
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 3649522
• MDR Text Key: 4196415
• Report Number: 3649522
• Device Sequence Number: 1
• Product Code: FTA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 88-9760
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2014
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 61