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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN MORTON LTD. ASR BULK NO. 15T BLADE SCALPEL BLADE

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SWANN MORTON LTD. ASR BULK NO. 15T BLADE SCALPEL BLADE Back to Search Results
Catalog Number R392
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Event Description
The customer reported that during the surgical procedure, the blade from the scalpel broke in half inside the patient's knee. A larger incision needed to be made to remove the broken piece. The broken blade was removed in one piece and per protocol, an xray was taken to verify there was no product left behind. There was no harm to the patient or staff due to this broken scalpel blade.
 
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Brand NameASR BULK NO. 15T BLADE
Type of DeviceSCALPEL BLADE
Manufacturer (Section D)
SWANN MORTON LTD.
owlerton green
sheffield, , gb S6 2B J
UK S6 2BJ
Manufacturer (Section G)
SWANN MORTON LTD.
owlerton green
sheffield, , gb S6 2B J
UK S6 2BJ
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key13319091
MDR Text Key287207394
Report Number9611194-2022-00001
Device Sequence Number1
Product Code GES
UDI-Device Identifier05033955183929
UDI-Public05033955183929
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberR392
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/21/2022 Patient Sequence Number: 1
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