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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN BARD-PARKER BLADE, SCALPEL

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ASPEN BARD-PARKER BLADE, SCALPEL Back to Search Results
Catalog Number 371153
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/16/2017
Event Type  malfunction  
Event Description
While using the blade it fell apart into multiple pieces. This caused the surgeon to have to convert the procedure from laparoscopic to open and search the wound for the blade pieces. A piece had to be retained due to not being able to safely retrieve it.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN
michelle pulaski
6945 southbelt drive se
caledonia MI 49316
MDR Report Key7112221
MDR Text Key94666831
Report Number7112221
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 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number371153
Other Device ID Number#15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/06/2017
Event Location Hospital
Date Report to Manufacturer12/06/2017
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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