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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN MORTON, LTD. CARBON STEEL BLADE #15 BLADE, SCALPEL

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SWANN MORTON, LTD. CARBON STEEL BLADE #15 BLADE, SCALPEL Back to Search Results
Model Number D6205
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2017
Event Type  malfunction  
Manufacturer Narrative
Root cause: the blade is supplied to deroyal by (b)(4). In a supplier corrective action response (scar), (b)(4) stated the true root cause of the reported issue is undetermined. The potential root cause could be, but is not limited to, end user error. As the blade was broke when it was being removed from the handle, it is possible the blade was being used on a damaged or worn handle. Corrective action: in its scar response, (b)(4) stated due to the investigation and root cause determination, a corrective action has not been taken investigation summary: an internal complaint ((b)(4)) was received indicating a carbon steel blade (part number d6205) broke when removing it from the scalpel handle post procedure. When it broke, the blade propelled across the or room. No injuries were reported as a result of this incident. The defective sample was discarded and not available for return. The customer returned a like sample for review on december 13, 2017. Because a lot number was not reported, the complaint investigator was unable to review the work order for discrepancies that may have contributed to the event. The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints. A similar complaint for the reported item was identified. A scar was issued december 2, 2017, to the device manufacturer, (b)(4) and a response has been received. Preventive action: due to the investigation and root cause determination, a preventive action has not been taken. The investigation is complete at this time. If new and critical information is received, this report will be updated.
 
Event Description
After a procedure, when removing a scalpel blade from a handle, the blade fractured and propelled across the operating room.
 
Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received indicating a carbon steel blade (part number d6205) broke when removing it from the scalpel handle post procedure. When it broke, the blade propelled across the or room. No injuries were reported as a result of this incident. The defective sample was discarded and not available for return. Because a lot number was not reported, the complaint investigator was unable to review the work order for discrepancies that may have contributed to the event. The 2014-2016 supplier corrective action (scar) and supplier notification letter logs were reviewed for similar complaints. A similar complaint for the reported item was identified. A scar was issued december 2, 2017, to the device manufacturer, (b)(4). As of the date of this report, a response to the scar has not been received. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
 
Event Description
After a procedure, when removing a scalpel blade from a handle, the blade fractured and propelled across the or room.
 
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Brand NameCARBON STEEL BLADE #15
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
SWANN MORTON, LTD.
owlerton green
sheffield, sheffield
UK
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1703 highway 33 south
new tazewell TN 37825
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key7154139
MDR Text Key266081520
Report Number1060680-2017-00022
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD6205
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/01/2017
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 Initial

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