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U.S. Department of Health and Human Services

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

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AESCULAP AG CARBON STEEL SCALPEL BLADES #10 GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number BB510
Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). If additional information is received a follow up report will be submitted. Investigation: no product at hand. Only photos archived. We found that the sterile packaging is open at one side. Batch history review: the device quality and manufacturing history records will be checked for all the lot number (4509537648/4509299706) from the quality coordinator of the production plant. After review the report will be updated. No similar incidents have been filed with products from this batch. Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause. There is the possibility that the root cause of the problem is most probably manufacturing related. Rationale: without the product we cannot determine the exact cause but there is the possibility for a manufacturing error due to an improperly manufactured sealing.
 
Event Description
It was reported there is a crack/hole at the sterile package for two different lot numbers. The packaging problem was detected prior to surgery and all sterile packaging was checked with a lamplight. No other information has been provided. Associated medwatches: 9610612-2019-00218, 9610612-2019-00219 (this report).
 
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Brand NameCARBON STEEL SCALPEL BLADES #10
Type of DeviceGENERAL SURGICAL 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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8476219
MDR Text Key140740800
Report Number9610612-2019-00219
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 04/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB510
Device Catalogue NumberBB510
Device Lot Number4509299706
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/26/2019
Event Location No Information
Date Manufacturer Received03/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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