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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FINE SURGICAL INSTRUMENTS, INC. / ALLIED HEALTHCARE PRODUCTS, INC. GOMCO TYPE CIRCUMCISION DISPOSABLE CHROME PLATED NEW BO; GOMCO CLAMP, CIRCUMCISION
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FINE SURGICAL INSTRUMENTS, INC. / ALLIED HEALTHCARE PRODUCTS, INC. GOMCO TYPE CIRCUMCISION DISPOSABLE CHROME PLATED NEW BO; GOMCO CLAMP, CIRCUMCISION Back to Search Results
Catalog Number 28-855
Device Problem Difficult to Open or Close (2921)
Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888)
Event Date 10/03/2017
Event Type  Injury  
Event Description
Circumcision procedure performed by physician.A 1.3 disposable gomco was used.When it was time to tighten the clamp, physician was unable to completely tighten using the nut on the threaded post.When physician turned the night, it would spin around, but would not move down the threads to tighten the clamp.Due to the inability to completely tighten the clamp during the procedure, additional pressure and silver nitrate were applied by the physician to stoop the "oozing".After the procedure was completed, the gomco clamp was removed and inspected.A small defect was noted on the threads about midway down the post.
 
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Brand Name
GOMCO TYPE CIRCUMCISION DISPOSABLE CHROME PLATED NEW BO
Type of Device
GOMCO CLAMP, CIRCUMCISION
Manufacturer (Section D)
FINE SURGICAL INSTRUMENTS, INC. / ALLIED HEALTHCARE PRODUCTS, INC.
hempstead NY
MDR Report Key7057419
MDR Text Key92960824
Report NumberMW5073553
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 Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number28-855
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/24/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age1 YR
Patient Weight4
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