MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. ASPEN SURGICAL ALC PLUS; LIGHT HANDLE COVER STERILE

Model Number LT-ALC01

Device Problems Component Falling (1105); Contamination (1120)

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

Event Date 03/11/2015

Event Type  malfunction  

Event Description

During our case, the sterile light handle fell off the overhead operating light #3 in or 19 and landed on the sterile field.The mayo stand became contaminated.The scrub nurse removed the light handle from the field and changed her gloves.The mayo stand was then moved out and recovered to provide a new sterile field.

• Brand Name: ASPEN SURGICAL ALC PLUS
• Type of Device: LIGHT HANDLE COVER STERILE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: bradley liske ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 4694221
• MDR Text Key: 5712533
• Report Number: 1836161-2015-00021
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT-ALC01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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