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U.S. Department of Health and Human Services

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

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AESCULAP AG CARBON STEEL SCALPEL BLADES #11 GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number BB511
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2020
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with bb511-carbon steel scalpel blades #11. According to the complaint description, the scalpel blade no. 11 bbraun (lot: k9356329), presents loss of the wire in advance, requiring extra consumption. There was no described patient harm. Additional information was not provided nor available / was not available. Additional patient information is not available. The adverse event / malfunction is filed under (b)(4).
 
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Brand NameCARBON STEEL SCALPEL BLADES #11
Type of DeviceGENERAL SURGICAL INSTRUMENTS
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 Key11398726
MDR Text Key249477296
Report Number9610612-2021-00112
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB511
Device Catalogue NumberBB511
Device Lot NumberK9356329
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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