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); Material Integrity Problem (2978)

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

Event Date 04/03/2015

Event Type  malfunction  

Event Description

Sales representative (b)(6) emailed product complaint on trumpf light handles.Email stated, "i received a call today from my (b)(6) sales rep-my customer has had three times the disposable trumpf light handle falling off." after further discoveries- the patient was not affected by the handle.It hit the drape and the drape was thrown away and a new one was used.There was no lot number that was able to be connected to the handle.

• 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. se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 4734792
• MDR Text Key: 21791595
• Report Number: 1836161-2015-00025
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• 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: 04/09/2015
• Was Device Evaluated by Manufacturer?: No
• 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