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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #23 GENERAL SURGICAL INSTRUMENTS

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AESCULAP AG CARBON STEEL SCALPEL BLADES #23 GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number BB523
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera. We opened a closed dispenser packaging and made a visible inspection of an unused surgical blade bb523. Here we found no visible failure. Furthermore we made a visual inspection of the scalpel #4l bb085r. Here we found traces of usage but no failure. Hardness of the instrument was checked and according to specification, it is not in the allowable tolerance. Batch history review: 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. Conclusion and root cause: the root cause of the problem is most probably usage related. Rational: the higher than normal hardness only has increased strength as a consequence. Furthermore the ductility decreased but we do not regard this as the decisive reason. We assume that a mechanical overload or high leverage with the instrument as a causal factor. No similar incidents have been filed with products from this batch. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It was reported that a broken scalpel blade had to be removed from the abdomen. No surgery delay reported. No harm to the patient reported. Components in use listed as concomitant devices are: bb523 / carbon steel scalpel blades #2. Bb085r / scalpel #4l.
 
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Brand NameCARBON STEEL SCALPEL BLADES #23
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key6225292
MDR Text Key250111747
Report Number9610612-2017-00006
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
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 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model NumberBB523
Device Catalogue NumberBB523
Device Lot Number4507771097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/16/2016
Device Age5 MO
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
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: 01/05/2017 Patient Sequence Number: 1
Treatment
BB085R / SCALPEL #4L; BB523 /CARBON STEEL SCALPEL BLADES #2
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