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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER CARBON RIB-BACK BLADES BLADE, SCALPEL

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ASPEN SURGICAL BARD-PARKER CARBON RIB-BACK BLADES BLADE, SCALPEL Back to Search Results
Lot Number 0118976
Device Problem Material Fragmentation (1261)
Patient Problem No Information (3190)
Event Date 03/02/2017
Event Type  malfunction  
Event Description
Surgical tech was loading the surgical blade into the knife handle before the case was to start and the blade shattered into three pieces.
 
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Brand NameBARD-PARKER CARBON RIB-BACK BLADES
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt drive se
caledonia MI 49316
MDR Report Key6518306
MDR Text Key73588250
Report Number6518306
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number0118976
Other Device ID NumberDGW955101 P 8365408 SIZE 15 B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/14/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer04/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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