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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 Corroded (1131)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Investigation: due to the circumstances that we did not receive any products, an analytical investigation is not possible. As seen on pictures, the blade holder is manufactured by swann morton. According to information found on the manufacturers website, the blade handles used to be made of a nickel alloy. Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to specifications valid at the time of production. Conclusion and root cause: based on available information as well as the provided pictures we assume a related root cause. Rational: the yellowish shade of the handle is an indication for the possibility that the handle is made of a nickel alloy. Referring to electrochemical series nickel is more precious than iron of the carbon-steel alloy of the blade. Corrosion in contact-area between both materials with blood as electrolyte is possible. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
 
Event Description
Country of complaint: (b)(6). It was reported the when the package was opened there was no rust on the blade. After using it on a patient, there was rust found on the blade.
 
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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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key6535451
MDR Text Key250113229
Report Number9610612-2017-00204
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeMY
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 08/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberBB511
Device Catalogue NumberBB511
Device Lot NumberB6603818
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/17/2017
Event Location No Information
Date Manufacturer Received02/22/2017
Was Device Evaluated by Manufacturer? Yes
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: 05/01/2017 Patient Sequence Number: 1
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