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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #20

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AESCULAP AG CARBON STEEL SCALPEL BLADES #20 Back to Search Results
Model Number BB520
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: the device quality and manufacturing history records have been checked for the available lot number. The device history file has been checked and found to be according to our specification 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 the investigation the root cause of failure is most probably user related. A material or production error is excluded. It is liable that a mechanical overload situation led to the breakage. Corrective/preventive actions: is not necessary.
 
Event Description
Country of complaints: (b)(6). The scalpel blade is broken and a part of it was recovered with difficulty from the surgical field. All med watch submissions related to this report are: 9610612-2017-00195, 9610612-2017-00196.
 
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Brand NameCARBON STEEL SCALPEL BLADES #20
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key6455140
MDR Text Key71585326
Report Number9610612-2017-00195
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberBB520
Device Catalogue NumberBB520
Device Lot Number4507635095
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date03/24/2017
Device Age8 MO
Event Location No Information
Date Manufacturer Received03/08/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/13/2016
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: 04/03/2017 Patient Sequence Number: 1
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