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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #15

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AESCULAP AG CARBON STEEL SCALPEL BLADES #15 Back to Search Results
Model Number BB515
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: the blade is broken about 1/3 of the length from the distal end. The analysis of the fracture pattern illustrated a forced fracture due to overload. No pores, inclusions or foreign bodies could be found on the point of rupture. The edge is damaged, most likely caused by an overload situation, e. G. Too much pressure during cutting. Additionally, the damaged proximal end is also an indicator for an overload situation, e. G. Leverage during application. The device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production. No similar incidents have been filed with products from this batch. Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage. The breakage of the blade was most likely caused by an overload situation, e. G. Leverage and/or too much pressure during cutting, e. G. Hard tissue or bone. A capa is not necessary.
 
Event Description
It was reported that there was an issue with the product carbon steel scalpel blades # 15. The scalpel blade broke while cutting the oral mucosa during wisdom tooth extraction. The fragment fell into the throat but could be removed. No harm to patient reported. (b)(4).
 
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Brand NameCARBON STEEL SCALPEL BLADES #15
Type of DeviceSCALPEL BLADES
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
kerstin rothweiler
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key8901674
MDR Text Key154626980
Report Number9610612-2019-00545
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB515
Device Catalogue NumberBB515
Device Lot Number4510041066
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2018
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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