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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP INC AESCULAP SURGICAL INSTRUMENTS; GENERAL SURGICAL INSTRUMENTS
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AESCULAP INC AESCULAP SURGICAL INSTRUMENTS; GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number AESCULAP010
Device Problem Compatibility Problem (2960)
Patient Problem Laceration(s) (1946)
Event Date 09/29/2020
Event Type  Injury  
Manufacturer Narrative
If additional information or investigation results become available, a supplemental mdr will be provided.
 
Event Description
It was reported that there was an issue with an unspecified applier during a procedure.During a an operation involving the carotid, the applier caught the vessel and "tore" it; this occurred after releasing a clip.There was no harm to the patient and no surgical delay due to the reported event.Further details have been requested.
 
Event Description
No updates.
 
Manufacturer Narrative
Failure description - product not provided.Investigation - no product at hand nor pictures.Batch history review - due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Explanation and rationale, conclusion - without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Corrective action - no capa available.
 
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Brand Name
AESCULAP SURGICAL INSTRUMENTS
Type of Device
GENERAL SURGICAL INSTRUMENTS
Manufacturer (Section D)
AESCULAP INC
3773 corporate parkway
center valley PA 18034
MDR Report Key10742239
MDR Text Key213446710
Report Number2916714-2020-00610
Device Sequence Number1
Product Code GEF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAESCULAP010
Device Catalogue NumberAESCULAP010
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2020
Distributor Facility Aware Date11/09/2020
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CLIPS
Patient Outcome(s) Other;
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