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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #10

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AESCULAP AG CARBON STEEL SCALPEL BLADES #10 Back to Search Results
Model Number BB510
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 bb510. Here we found no visible failure. Hardness of the instrument was checked. The hardness was found to be higher than the specification. 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 user related. Rational: the high hardness has increased strength as a result, and is not likely the root cause. We assume that a mechanical overload or high leverage with the instrument as a causal factor. No similar incidents have been filed with the products from this batch. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
(b)(6). During the hip surgery three out of four blades broke near the knife handle during the processing of the capsule.
 
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Brand NameCARBON STEEL SCALPEL BLADES #10
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 Key6656661
MDR Text Key250323764
Report Number9610612-2017-00338
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeGM
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 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Model NumberBB510
Device Catalogue NumberBB510
Device Lot Number4508161655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/19/2017
Device Age6 MO
Event Location No Information
Date Manufacturer Received06/08/2017
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: 06/21/2017 Patient Sequence Number: 1
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