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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #22

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AESCULAP AG CARBON STEEL SCALPEL BLADES #22 Back to Search Results
Model Number BB522
Device Problems Incomplete or Missing Packaging (2312); Device Disinfection Or Sterilization Issue (2909); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: two package of sterile surgical blades arrived in a decontaminated condition and available for investigation. The pierced dispenser packaging are missing. There are no (b)(6) consequences for the patient. The investigation was complete by using photographs. The device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production. The root cause of the problem is most probably related to an improper transport or storage of the product. According to the quality standard and dhr files the product has been distributed in a condition complying with our specifications. Most likely the product was damaged by an improper transport or storage. A capa is not necessary.
 
Event Description
Country of complaint: (b)(6). It was reported that the knife has unsterile blades because the point of the knife have perforated the packages.
 
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Brand NameCARBON STEEL SCALPEL BLADES #22
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
MDR Report Key7230869
MDR Text Key98733103
Report Number9610612-2018-00022
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeNO
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
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberBB522
Device Catalogue NumberBB522
Device Lot Number4507996231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date01/10/2018
Device Age13 MO
Event Location No Information
Date Manufacturer Received07/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2016
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: 01/31/2018 Patient Sequence Number: 1
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