MAUDE Adverse Event Report: CENTURION; CIRCLAMP W/1.3CM BELL ST - REPROCESSED

Catalog Number 330CRK

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/01/2023

Event Type  Injury  

Event Description

According to the customer, upon removal of the gomco clamp after circumcision was performed there was "bleeding" noted.

Manufacturer Narrative

According to the customer, upon removal of the gomco clamp after circumcision was performed there was "bleeding" noted.The customer reported "separation of the layers of the skin around the cut", "excess skin on the dorsal aspect observed, suggestive of partial circumcision", and "a circumferential cut and dehiscence of the skin around the shaft of the penis at the base by the scrotum".The customer reported homeostasis was achieved with "manual pressure" utilizing "surgi-foam" and the site was cleansed and dressed.The customer reported a pediatric surgical consult was obtained.The customer did not report any device malfunction.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: CIRCLAMP W/1.3CM BELL ST - REPROCESSED
• Manufacturer (Section D): CENTURION; 301 catrell drive; howell MI 48843 1703
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18465218
• MDR Text Key: 332320767
• Report Number: 1824619-2024-00001
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2024

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: Health Professional
• Device Catalogue Number: 330CRK
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other