MAUDE Adverse Event Report: CAREFUSION, INC MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN; CLAMP, CIRCUMCISION

Model Number	GL7021
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) ¿ mw5118809.On (b)(6) 2023 writer sent the customer an email acknowledging receipt of the complaint and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
Event or Problem Description
It was reported by the customer that 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.Complaint received via email.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 (b)(6) right away to transfer the baby to (b)(6) 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 glansplasty was performed by the pediatric urologist at (b)(6) and the foley will remain in place for 10 days.No further information is not available.

• Brand Name: MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN
• Common Device Name: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17333882
• Report Number: 1423507-2023-00095
• Device Sequence Number: 11964403
• Product Code: HFX
• UDI-Device Identifier: 10885403001406
• UDI-Public: (01)10885403001406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/12/2023
• Report Date (Section F): 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GL7021
• Device Catalogue Number: GL7021
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/20/2023