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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Pain (1994)
Event Date 02/01/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: no product is available for investigation. Batch history review: the device quality and manufacturing history records have been checked for the available lot number. The device history file has been checked and found to be according to our specification valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: based on the information available and the quality standards we exclude a material or manufacturer related error. Rational: we can not detect a causal relation between the products and the mentioned patient hazard. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
 
Event Description
Country of complaint: (b)(6). Nerve injury (spinal opening) during median nerve release interventions during several interventions called carpal tunnel with patient outcomes complaining of scar burn and in the median nerve area. Scar burns (about 10 for 50 procedures) in the median nerve area with algodystrophy (3 out of 10) and prolongation of sick leave for some patients.
 
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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
3145515988
MDR Report Key6918007
MDR Text Key253309844
Report Number9610612-2017-00501
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeRE
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 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB515
Device Catalogue NumberBB515
Device Lot NumberL8202262
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date10/04/2017
Event Location No Information
Date Manufacturer Received09/15/2017
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: 10/05/2017 Patient Sequence Number: 1
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