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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP, INC. GOMCO CIRCUMCISION CLAMP; CLAMP, CIRCUMCISION
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AESCULAP, INC. GOMCO CIRCUMCISION CLAMP; CLAMP, CIRCUMCISION Back to Search Results
Device Problems Misassembled (1398); Device Markings/Labelling Problem (2911); Device-Device Incompatibility (2919); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Information (3190)
Event Date 05/19/2016
Event Type  malfunction  
Event Description
Patients undergoing circumcision with a gomco device, same type/named device from both manufacturers.The component parts will fit into each other from different manufacturers but ultimately will not perform the expected function correctly.The mis-match (look alike components) are not marked by the manufacturer and therefore create mis-identification during assembly.An added patient safety measure would be for each manufacturer to mark their components to prevent assembly of none matching parts.The procedure can be underway with poor performance from the gomco.In one case, a patient required intervention of a suture secondary to the poor performing mismatched gomco components.
 
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Brand Name
GOMCO CIRCUMCISION CLAMP
Type of Device
CLAMP, CIRCUMCISION
Manufacturer (Section D)
AESCULAP, INC.
3773 corporate parkway
center valley PA 18034
MDR Report Key5917003
MDR Text Key53662887
Report Number5917003
Device Sequence Number1
Product Code HFX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/14/2016,07/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2016
Is this a Product Problem Report? Yes
Device Operator Physician
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/14/2016
Event Location Hospital
Date Report to Manufacturer06/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
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