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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #15 GENERAL SURGICAL INSTRUMENTS

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AESCULAP AG CARBON STEEL SCALPEL BLADES #15 GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number BB515
Device Problem Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: pending further information.
 
Event Description
It was reported by the healthcare professional to the company sales representative "blades are not sharp enough". Customer information update: "there was no patient hazard or harm during the surgery. But the consultant plastic & reconstructive surgeon had difficulties in precise incision during the surgery. Ultimately this may affect the post-operative cosmetic results of the patient".
 
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Brand NameCARBON STEEL SCALPEL BLADES #15
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8017102
MDR Text Key125672559
Report Number9610612-2018-00487
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeCE
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,Followup
Report Date 12/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB515
Device Catalogue NumberBB515
Device Lot Number4508116972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/23/2018
Device Age21 MO
Event Location No Information
Date Manufacturer Received11/23/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/30/2016
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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