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U.S. Department of Health and Human Services

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

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AESCULAP AG CARBON STEEL SCALPEL BLADES #10 BASIC INSTRUMENTS Back to Search Results
Model Number BB510
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: thirty-six unopened dispenser packaging of lot 4510101361, were received. They arrived in a decontaminated condition and they are available for investigation. Investigation - the investigation was carried out visually and microscopically. We also made an optical inspection of the arrived unopened dispenser packaging. Here we detected no visible damaged dispenser packaging of the package. There were some found with suspected visible damage. Furthermore, the products were sent to the production department for further investigations. The report will be updated when we receive a statement from that department. Batch history review - the device quality and manufacturing history records will be checked for the lot number. Once the quality coordinator of the production plant checks it, the report will be updated. No similar incidents have been filed with products from these batches. Conclusion and root cause - there is the possibility that the root cause of the problem is related to an improper transport of the product. The report will be updated after further investigation from the production department. Rationale - due to the circumstance that the products have been sent to the manufacturer for an analysis, this is a preliminary report. There is the possibility that the holes or cracks and suspected visible damage were caused due to an improper transport of the product. There is also the possibility that the cause could be traced back to an increased load, e. G. Drops, impacts or similar, during transport. A capa was initiated and completed.
 
Event Description
It was reported that there was an issue with the scalpel package. Prior to surgery, it was noted that there was a hole or crack in the sterile packet. The device was not used on a patient. There was no additional information.
 
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Brand NameCARBON STEEL SCALPEL BLADES #10
Type of DeviceBASIC 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
lindsay chromiak
3773 corporate parkway
center valley, PA 18034
MDR Report Key8601508
MDR Text Key144968591
Report Number9610612-2019-00315
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeNO
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 05/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB510
Device Catalogue NumberBB510
Device Lot Number4510101361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/03/2019
Event Location No Information
Date Manufacturer Received04/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2018
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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