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U.S. Department of Health and Human Services

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

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AESCULAP AG CARBON STEEL SCALPEL BLADES #11 BLADE, SCALPEL Back to Search Results
Model Number BB511
Device Problem Dull, Blunt (2407)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturer evaluation: investigation on-going. Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
Event Description
It was reported to aesculap ag that a carbon steel scalpel blades #11 (part # bb511) was used during an unknown procedure performed on march 2, 2021. According to the complainant, the scalpel blade was blunt. The complaint device was returned to the manufacturer for evaluation. No patient complications were reported as a result of the event. Although requested, additional information has not been made available. The malfunction is filed under aag reference (b)(4).
 
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Brand NameCARBON STEEL SCALPEL BLADES #11
Type of DeviceBLADE, SCALPEL
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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key11734922
MDR Text Key253236270
Report Number9610612-2021-00343
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeIN
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 10/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB511
Device Catalogue NumberBB511
Device Lot Number4511854298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2020
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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