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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XODUS MEDICAL, INC. XODUS REUSABLE SAFETY SCALPEL BLADE, SCALPEL - SURGICAL SCALPEL BLADES

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XODUS MEDICAL, INC. XODUS REUSABLE SAFETY SCALPEL BLADE, SCALPEL - SURGICAL SCALPEL BLADES Back to Search Results
Model Number 90150
Device Problems Retraction Problem (1536); Device Slipped (1584); Difficult to Advance (2920)
Patient Problem Laceration(s) (1946)
Event Date 01/03/2017
Event Type  malfunction  
Event Description
After attaching the #15 safety blade to blade handle, attempted to retract yellow safety mechanism; unable to retract. Safety blade device requires force in a forward motion to retract yellow safety cover. Took off the safety blade to reattach and attempt again. Retracted yellow safety mechanism and the blade slipped out of yellow safety mechanism and cut second finger/hand.
 
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Brand NameXODUS REUSABLE SAFETY SCALPEL
Type of DeviceBLADE, SCALPEL - SURGICAL SCALPEL BLADES
Manufacturer (Section D)
XODUS MEDICAL, INC.
702 prominence dr.
new kensington PA 15068
MDR Report Key6245224
MDR Text Key64642585
Report Number6245224
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 01/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/07/2021
Device Model Number90150
Device Catalogue Number90150
Device Lot Number16AUG26
Other Device ID NumberSAFETY CARTRIDGE #15 STAINLES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/11/2017
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/11/2017
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?
Type of Device Usage

Patient Treatment Data
Date Received: 01/12/2017 Patient Sequence Number: 1
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