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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RIB-BACK CARBON STEEL SURGICAL BLADE BLADE, SCALPEL

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ASPEN SURGICAL PRODUCTS, INC. RIB-BACK CARBON STEEL SURGICAL BLADE BLADE, SCALPEL Back to Search Results
Catalog Number 0086
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2020
Event Type  Injury  
Event Description
A #10 scalpel blade was used for initial skin incision during a cesarean section and immediately placed into the sharps box on the back table. Upon review of the sharps box, it was discovered that the tip of the scalpel had broken off. The surgeon, was notified and an immediate search of the room was initiated with xray ordered. Surgeon was confident that the blade was intact when she used it for the skin incision, and that the tip was also not in the abdomen. The patient was then closed. A magnet was used to try to find the piece in the area surrounding the patient and over the sponges, etc and a floor magnet roller was used for the floor. The tip was not found. The xray report showed 2 clips from prior appendectomy, but no blade tip. The patient was educated that the tip had broken off but all precautions were taken to ensure the tip was not inside. The tip was not found despite all attempts. Staff sequestered the blade and plan to return to the vendor. Pictures of the blade and packaging were also taken. Fda safety report id# (b)(4).
 
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Brand NameRIB-BACK CARBON STEEL SURGICAL BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
MDR Report Key10436410
MDR Text Key204195282
Report NumberMW5096170
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 08/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0086
Device Lot Number0223350
Was Device Available for Evaluation? Yes
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

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