MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. CARDINAL ECOCHOICE; LIGHT HANDLE NON-STERILE

Model Number LT-EH01NS

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

The customer stated: the light handle does not fit properly and has fallen off.This was reported on the minor set up pack.No injury was reported.

• Brand Name: CARDINAL ECOCHOICE
• Type of Device: LIGHT HANDLE NON-STERILE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 4613820
• MDR Text Key: 5656818
• Report Number: 1836161-2015-00012
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT-EH01NS
• Device Lot Number: 61051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2015
• 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