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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
No product is at hand. 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 our investigation the root cause of the failure is most probably related to an insufficient usage. Based on the quality standards, we exclude a material or manufacturing caused error. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
 
Event Description
Country of complaint: (b)(6). The blades #11 do not adapt to the cable, the blade enters with great difficulty and when it is withdrawn, it breaks down completely, causing a risk of accidental cutting.
 
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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 Key7114398
MDR Text Key249207134
Report Number9610612-2017-00594
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberBB511
Device Catalogue NumberBB511
Device Lot Number4508500545
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/01/2017
Device Age7 MO
Event Location No Information
Date Manufacturer Received11/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2017
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: 12/13/2017 Patient Sequence Number: 1
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