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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN-MORTON, LTD. SWANN-MORTON SCALPEL BLADE

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SWANN-MORTON, LTD. SWANN-MORTON SCALPEL BLADE Back to Search Results
Model Number CARBON STERILE SURGICAL BLADE
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
The following response has been sent to the customer, "thank you for informing us of your customer complaint regarding one of our carbon sterile sm10 blades breaking during use. It states in the complaint report that the item is breaking whilst being used on the patient. At this stage, we are unsure of the surgical procedure that the blade was used in, and also we are led to believe that we will not be receiving the blade in question or any further samples from the same lot number or shelf box for us to investigate. With this blade breaking during surgery, it must be reported to the mhra and the fda as it falls into the category of an adverse incident. Checking through our records with the lot number you have provided, we can confirm to the best of our knowledge we have received no further customer complaints of this nature, of which (b)(4) carbon sterile sm10 blades were produced and sold. Due to us not knowing the surgical procedure that this blade was used in, or not having the broken blade in question returned we do find it difficult to comment further on how it became to break during use. If samples of further information were to become available, we would be able to perform a thorough investigation and issue you with a further, more detailed report of our findings. If we can be of any further assistance, please do not hesitate to contact us. ".
 
Event Description
The only information returned by the customer was "the item is breaking while being used on the patient" and no sample has been returned for review.
 
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Brand NameSWANN-MORTON
Type of DeviceSCALPEL BLADE
Manufacturer (Section D)
SWANN-MORTON, LTD.
owlerton green
sheffield, gb
UK
Manufacturer (Section G)
SWANN-MORTON, LTD.
owlerton green
sheffield, gb
UK
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key11016154
MDR Text Key234300862
Report Number9611194-2020-00002
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 Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCARBON STERILE SURGICAL BLADE
Device Catalogue Number0201
Device Lot Number3722004
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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