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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 Problems Failure to Cut (2587); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
 
Event Description
(b)(6). It was reported that the blade did not cut.
 
Manufacturer Narrative
Investigation: no product is at hand. Batch history review: the device history records have been checked and found to be according to the specification, valid at the time of production. There is no indication for a material failure or a manufacturing defect. No further complaint registered against the same batch number. Conclusion and root cause: based on the information available, the root cause of the failure is most probably related to an insufficient usage. Rational: based on the quality standards, we exclude a material or manufacturer caused error. It is possible that an insufficient usage resulted in the described failure. No capa is necessary.
 
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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
MDR Report Key7434522
MDR Text Key105691281
Report Number9610612-2018-00187
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
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model NumberBB515
Device Catalogue NumberBB515
Device Lot Number4508746528
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/09/2018
Device Age1 YR
Event Location No Information
Date Manufacturer Received03/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/16/2018 Patient Sequence Number: 1
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