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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #11

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AESCULAP AG CARBON STEEL SCALPEL BLADES #11 Back to Search Results
Model Number BB511
Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: this instrument is not available for investigation. According to the available information, there were no negative consequences for the patient. The device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production. No similar incidents have been filed with products from this batch. No product available and therefore it is hardly possible to determine an exact conclusion and root cause. It is assumed that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. A capa is not necessary.
 
Event Description
It was reported by the healthcare professional to the company sales representative "during surgery when the blade was opened it appeared to have rust and dirt on it.
 
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Brand NameCARBON STEEL SCALPEL BLADES #11
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 Key7996601
MDR Text Key125612616
Report Number9610612-2018-00477
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB511
Device Catalogue NumberBB511
Device Lot NumberY9021051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/10/2018
Event Location No Information
Date Manufacturer Received09/28/2018
Was Device Evaluated by Manufacturer? Yes
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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