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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA TRUMPF DISPOSABLE LIGHT HANDLE; LIGHT HANDLE COVER
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ASPEN SURGICAL PRODUCTS, CALEDONIA TRUMPF DISPOSABLE LIGHT HANDLE; LIGHT HANDLE COVER Back to Search Results
Model Number LT-ALC01
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/29/2015
Event Type  malfunction  
Manufacturer Narrative
No sample available from customer.
 
Event Description
Disposable light handle does not fit onto light handle correctly.When installed, the product seems to fit tightly onto the light handle, and gives the appearance of being locked on, but it does not easily lock into place.When surgeon or staff grasps the light handle to move the light, the disposable handle falls off because it's not locked into place.
 
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Brand Name
TRUMPF DISPOSABLE LIGHT HANDLE
Type of Device
LIGHT HANDLE COVER
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer Contact
bradley liske
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key5455052
MDR Text Key39259027
Report Number1836161-2016-00013
Device Sequence Number1
Product Code FTA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK020304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/29/2016
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 Health Professional
Device Model NumberLT-ALC01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/29/2016
Initial Date FDA Received02/23/2016
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 Number1
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