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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 Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). While performing surgery, the aforementioned leaves did not cut cartilage, it even cost them to cut skin. It had to use 14 sheets to achieve the goal. Consequences of non-compliance: 14 sheets cannot be loaded to the patient, surgeon non-compliance wo requires changing supplier, process performed without necessary quality. Also, please note that this fact had already occurred in isolation in two surgeries.
 
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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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key7687231
MDR Text Key113969545
Report Number9610612-2018-00307
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB515
Device Catalogue NumberBB515
Device Lot Number4508804701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/23/2018
Device Age10 MO
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2017
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: 07/13/2018 Patient Sequence Number: 1
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