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U.S. Department of Health and Human Services

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

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AESCULAP AG CARBON STEEL SCALPEL BLADES #15 Back to Search Results
Model Number BB515
Device Problems Break (1069); Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 11/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: the instrument arrived in a decontaminated condition and available for investigation. The broken fragment is missing. During a surgery the scalped blade broke off and the patient swallowed a fragment. This fragment could be retrieved endoscopically. Hereinafter another scalped blade was used and it broke off into pieces also. The swallowed fragment could be retrieved via gastroscopy and an additional anesthesia was not needed. The surgical blade arrived in a clean status with visible damage but without the broken off fragment. The components have been examined visually and microscopically with the digital microscope. A visual inspection of the instrument was performed and discoloration was found. Additional visual inspection was performed of the fracture surface. A light brown discoloration was found. 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 usage related. According to the quality standard and dhr files a material defect and production error can be excluded. The breakage was caused by a mechanical overload situation. There is a possibility for an improper handling. A capa is not necessary.
 
Event Description
(b)(6). During oral surgery the scalpel blade broke off and the patiet swallowed a fragment. This fragment could be retrieved endoscopically. Hereinafter another scalpel blade was used and it broke broke off into pieces also.
 
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Brand NameCARBON STEEL SCALPEL BLADES #15
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 Key7305778
MDR Text Key101355647
Report Number9610612-2018-00068
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
PMA/PMN Number
EXCEPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB515
Device Catalogue NumberBB515
Device Lot NumberP8581576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Was the Report Sent to FDA?
Distributor Facility Aware Date02/23/2018
Event Location No Information
Date Manufacturer Received02/01/2018
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: 03/01/2018 Patient Sequence Number: 1
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