• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #23

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG CARBON STEEL SCALPEL BLADES #23 Back to Search Results
Model Number BB523
Device Problem Dull, Blunt (2407)
Patient Problem No Information (3190)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
Information received by received - an automated system for receipt of adverse events in (b)(6. Limited information, including details of the incident were provided. Information received indicates that the scalpel blades did not cut during use. Five material / lot number combinations were provided. All medwatch reports associated with the report from notivisa include the following: 9610612-2018-00443, 9610612-2018-00444, 9610612-2018-00445, 9610612-2018-00446, 9610612-2018-00447 (this report).
 
Manufacturer Narrative
All medwatch reports associated with this report: 9610612-2018-00443, 9610612-2018-00444, 9610612-2018-00445, 9610612-2018-00446, 9610612-2018-00447. Investigation: no product is at hand. Batch history review: the device quality and manufacturing history records have been checked for all the lot numbers (4508507992/4508827131/4508948992) and found to be according to the specification, valid at the time of production. No similar incidents have been filed with products from these batches. Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rationale: unfortunately, due to a lack of data and without the product we can not determine the exact cause. According to the quality standard and dhr files, a material defect or production error can be excluded. There is the possibility for a usage error. No capa is necessary.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARBON STEEL SCALPEL BLADES #23
Type of DeviceSCALPEL BLADE
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key7916609
MDR Text Key122012114
Report Number9610612-2018-00447
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 foreign,other
Type of Report Initial,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model NumberBB523
Device Catalogue NumberBB523
Device Lot Number4508547054
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date09/21/2018
Device Age10 MO
Event Location No Information
Date Manufacturer Received10/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-