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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR BLADE 3.5MM DSPL EP-1 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. INCISOR BLADE 3.5MM DSPL EP-1 SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/15/2021
Event Type  Injury  
Event Description
It was reported that during a knee scope procedure with the incisor blade, there were black marks on the tissue. Looks like black marker was used on the tissue after the inner tube touched tissue. The procedure was completed with a s+n back up device. No delay and no patient complications were reported.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
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Brand NameINCISOR BLADE 3.5MM DSPL EP-1
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12928628
MDR Text Key281719341
Report Number1219602-2021-02643
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205312
Device Catalogue Number7205312
Device Lot Number50920998
Was Device Available for Evaluation? No
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
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