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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE
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ASPEN SURGICAL PRODUCTS, CALEDONIA ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE Back to Search Results
Model Number LT-F01B
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.
 
Event Description
Aspen surgical received a report from the distributor indicating that a light handle cover was discovered with a sealing issue.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).
 
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Brand Name
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE
Type of Device
LIGHT HANDLE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
jordan hackert
6945 southbelt dr. s.e.
caledonia, MI 49316
6165367508
MDR Report Key9438793
MDR Text Key191437762
Report Number1836161-2019-00098
Device Sequence Number1
Product Code FTA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K020304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberLT-F01B
Device Lot Number146084
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/11/2019
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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