MAUDE Adverse Event Report: TRI-STATE DE MEXICO, S. DE R.L. DE C.V; CIRCLAMP W/1.3CM BELL ST - REPROCESSED

Catalog Number	330CRK
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on 3/11, "a circumcision was completed using circlamp.Bright, red bleeding was noted twice and required surgicel application for intervention approximately 17 hours after procedure completed" a sample 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 3/11, "a circumcision was completed using circlamp.Bright, red bleeding was noted twice and required surgicel application for intervention approximately 17 hours after procedure completed.".
Additional Manufacturer Narrative
Updated: d9- "returned to manufacturer" is checkmarked and updated "date returned to manufacturer" to 5/21/2024.H3- "yes".H6:b- "10".

• Common Device Name: CIRCLAMP W/1.3CM BELL ST - REPROCESSED
• Manufacturer (Section D): TRI-STATE DE MEXICO, S. DE R.L. DE C.V; calzada presidente venustiano; desarollo industrial colorado; mexicali baja california, 21397 ; MX 21397
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19291176
• Report Number: 3004519921-2024-00027
• Device Sequence Number: 20995048
• 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,Followup
• Report Date (Section B): 07/01/2024

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
• Device Lot Number: 2024012590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 3 KG