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

Catalog Number	330CRK
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on 3/15/2024, "circlamp was used for male circumcision and surgicel was applied to stop excessive bleeding.Surgery was not required".The product is available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer on 3/15/2024, "circlamp was used for male circumcision and surgicel was applied to stop excessive bleeding.Surgery was not required".

• Common Device Name: CIRCLAMP W/1.3CM BELL ST - REPROCESSED
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS, LP; 301 catrell drive; howell MI 48843 1703
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19124649
• Report Number: 1824619-2024-00006
• Device Sequence Number: 15365543
• Product Code: HFX
• UDI-Device Identifier: 10653160309901
• UDI-Public: 10653160309901
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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 Catalogue Number: 330CRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown