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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 Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation: we received 250 carbon steel scalpel blades #15: 236, unopened, no deviation found with the naked eye. 4, no deviation found with the naked eye-opened by customer. 5, anti-rust inlay misplaced- opened by customer. 3, anti-rust inlay misplaced- opened by vigilance investigator. 2, unopened, but without lot stamp. One pack included two blades the peel packaging of eight blades are not sealed correctly since the anti-corrosion-inlay is not at the right position. Batch history review the device quality and manufacturing history records for the available lot numbers have been requested at the responsible q-coordinator of the production plant. The answer is still pending. This report will be updated upon receipt of the review confirmation. No similar incidents have been filed with products from this batch. Conclusion and root cause: based on the information available as well as a result of out investigation the root cause of the failure is related to a manufacturing error. Rationale the detected error can be attributed to a production error. A capa has been initiated.
 
Event Description
It was reported insufficient sealing. The reporter indicated during surgery the blade packages were looked at and it was found they were not sealed resulting in a sterility problem. No patient harm. Additional information has been requested, however, not yet received.
 
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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
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
lindsay chromiak
3773 corporate parkway
center valley, PA 18034
8002581946
MDR Report Key8671889
MDR Text Key147477119
Report Number9610612-2019-00360
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 Other Health Care Professional
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB515
Device Catalogue NumberBB515
Device Lot Number4509746734
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/27/2019
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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