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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #11

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AESCULAP AG CARBON STEEL SCALPEL BLADES #11 Back to Search Results
Model Number BB511
Device Problems Failure to Cut (2587); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It was reported that several blades does not cut, use of 3-4 blades per intervention.
 
Manufacturer Narrative
Investigation: no product is at hand. Batch history record: 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 of a material or manufacturing defect. No other complaints are filed with materials with this 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 #11
Type of DeviceSCALPEL BLADES
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key7685215
MDR Text Key113888492
Report Number9610612-2018-00277
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 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model NumberBB511
Device Catalogue NumberBB511
Device Lot Number4507752624
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/13/2018
Device Age2 YR
Event Location No Information
Date Manufacturer Received06/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/13/2018 Patient Sequence Number: 1
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