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U.S. Department of Health and Human Services

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

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AESCULAP AG CARBON STEEL SCALPEL BLADES #15 BLADE, SCALPEL Back to Search Results
Model Number BB515
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturer evaluation: investigation on-going. Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
Event Description
It was reported to aesculap ag that a carbon steel scalpel blades #15 (part # bb515) was used during an unknown procedure performed on (b)(6) 2021. According to the complainant, while performing surgery on hard tissues, capsule and tendon, the physician noted that the blade lost the cutting edge too fast. The complaint device has not been returned to the manufacturer for evaluation. No patient complication were reported as a result of the event. Although requested, additional information has not been made available. The malfunction is filed under (b)(4).
 
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Brand NameCARBON STEEL SCALPEL BLADES #15
Type of DeviceBLADE, SCALPEL
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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key11987576
MDR Text Key256014022
Report Number9610612-2021-00443
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB515
Device Catalogue NumberBB515
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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