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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #12D GENERAL SURGICAL INSTRUMENTS

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AESCULAP AG CARBON STEEL SCALPEL BLADES #12D GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number BB542
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with bb542 - carbon steel scalpel blades #12d. According to the complaint description, it was reported that the blades broke inside patient's mouth and remained in the gum. Additional information received, that three scalpel blades of the mentioned type of it happened that the tip of the blade broke off during a standard operation ("unfolding"). The broken off parts were about 0. 5mm to 1mm long. There were no patient injuries, i. E. Up to now such injuries are not known. However, it can not rule out the possibility that further splinters of the blades may be discovered in future x-rays. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameCARBON STEEL SCALPEL BLADES #12D
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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key11148321
MDR Text Key226079448
Report Number9610612-2020-00967
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeSZ
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
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB542
Device Catalogue NumberBB542
Device Lot Number4510945749
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
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: 01/11/2021 Patient Sequence Number: 1
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