MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORPORATION CENTURION; CLAMP, CIRCUMCISION

Model Number 330CRK

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Swelling/ Edema (4577)

Event Date 11/01/2023

Event Type  Injury  

Event Description

From staff: infant presented to the clinic for newborn circumcision.Circumcision using a disposable gomco device was performed by resident physician under the direct supervision of a preceptor.Complication of procedure was recognized upon removal of the gomco device due to unexpected result and bleeding.A faculty physician was called into the room to evaluate and requested additional staff to come to evaluate.From procedure not: the bell of a 1.3-diameter gomco circumcision apparatus was placed over the glans, and the foreskin was pulled over the bell and held in place with a sterile curved mosquito hemostat.The foreskin was positioned for excision as the gomco apparatus was assembled.Adequate hemostasis was obtained, and foreskin was then excised.The gomco assembly was removed.Upon removal of the bell, a separation of the layers of the skin around the cut was noticed, with swelling of the inner most layer.There was bleeding from the 3 o'clock position, initially controlled with bleeding.Excess skin on the dorsal aspect observed, suggestive of a partial circumcision.Additional adhesions were taken down with gentle traction to reveal the head of the penis and assess further for extent of excess foreskin and next steps.At this time, bleeding intensified and upon inspection of the penis, revealed a circumferential cut and dehiscence of the skin around the shaft of the penis at the base by the scrotum.Pressure was applied and assistance from two additional attending physicians.Hemostasis ultimately achieved with surgi-foam and continuous pressure.Case presented to pediatric surgical team, who graciously agreed to see him in their office this afternoon.The operative site was cleaned and dressed with white petroleum and a 4 x 4 gauze pad.The patient was returned to his mother in stable condition.Complications and plan were discussed with mom in detail, who verbalized understanding and agreement to this plan.They left the office in stable condition by private vehicle.

• Brand Name: CENTURION
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 301 catrell dr; howell MI 48843
• MDR Report Key: 18300241
• MDR Text Key: 330159323
• Report Number: 18300241
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2023

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?: No
• Device Operator: Other
• Device Model Number: 330CRK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2023
• Event Location: Other
• Date Report to Manufacturer: 12/11/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 DA
• Patient Sex: Male
• Patient Weight: 4 KG