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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER STAINLESS STEEL SURGICAL BLADE BLADE, SCALPEL

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ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER STAINLESS STEEL SURGICAL BLADE BLADE, SCALPEL Back to Search Results
Lot Number 0154772
Device Problems Break (1069); Device Fell (4014)
Patient Problem No Code Available (3191)
Event Date 08/17/2018
Event Type  Injury  
Event Description
Pt undergoing an arthroscopy with partial medial and lateral meniscectomy to left knee. When surgeon was using the product to create access for the scope, the surgical blade broke in half with the tip falling into the pt's knee. Surgeon had to do a 3 inch incision to retrieve the surgical tip. No further issues, procedure otherwise went well.
 
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Brand NameBARD-PARKER STAINLESS STEEL SURGICAL BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
MDR Report Key7869181
MDR Text Key120191802
Report NumberMW5079745
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0154772
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/11/2018 Patient Sequence Number: 1
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