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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #22 BASIC INSTRUMENTS

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AESCULAP AG CARBON STEEL SCALPEL BLADES #22 BASIC INSTRUMENTS Back to Search Results
Model Number BB522
Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 05/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation: the peel packaging of the blades are not sealed correctly. One side of the peel is open, the anti-corrosion-inlay is not at the right position. Batch history review: the device quality and manufacturing history record have been checked for the available lot number and found to be according to our specifications valid at the time of production. 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 our investigation the root cause of the failure is most probably related to a manufacturing error. Rationale: the detected error can be attributed to a production error.
 
Event Description
It was reported the packages had insufficient sealing. The reporter indicated that in almost every case the packages of the scalpel blades were completely open. The blades were falling out of the package. This event was noticed prior to surgery, therefore no harm to the patients.
 
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Brand NameCARBON STEEL SCALPEL BLADES #22
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
8002581946
MDR Report Key8660347
MDR Text Key147164820
Report Number9610612-2019-00363
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeHU
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 05/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB522
Device Catalogue NumberBB522
Device Lot Number4509960181
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/21/2019
Device Age5 MO
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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