MAUDE Adverse Event Report: V. MUELLER/CAREFUSION 2200, INC. MOGEN CIRCUMCISION CLAMP; CLAMP, CIRCUMCISION

Model Number GL7021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 05/24/2023

Event Type  Injury  

Event Description

Consent obtained by rn.Rn did confirm that md had gone over the risks and benefits before she obtained the parent's signature and witnessed the consent.Md used a mogan clamp to perform the procedure.A time out was performed prior to the procedure.Md proceeded with the procedure and used the clamp.Probe was used to lyse adhesions between foreskin and glans.Mogen clamp was placed bevel down.Foreskin was cut with scalpel.When clamp was removed, the baby was noted to be bleeding and a portion of the right glans was cut off in the cut foreskin.The piece of the glans was retrieved and placed immediately on ice while pressure was applied by another md the entire time.Continuous pressure applied to glans for hemostasis.The neonatologist was called right away and the baby was transferred to the nicu.The nicu called stanford right away to transfer the baby to stanford to have urology reattach cut off portion of the glans, and the team gave us an eta of 20 minutes.Md did inform the parents right away of the complication and the parents went to the nicu once the baby was transferred.An iv was started in the nicu while pressure was still being applied to the circumcision site the entire time.The following morning the neonatologist stated that the 5mm glans had been reattached and is still pink.A uroplasty and glans plasty was performed by the pediatric urologist at stanford and the foley will remain in place for 10 days.

• Brand Name: MOGEN CIRCUMCISION CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): V. MUELLER/CAREFUSION 2200, INC.
• MDR Report Key: 17201533
• MDR Text Key: 318038092
• Report Number: MW5118809
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GL7021
• Device Catalogue Number: GL7021
• Device Lot Number: 2201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Weight: 3 KG