MAUDE Adverse Event Report: CENTURION; CIRCLAMP W/1.1CM BELL ST- REPROCESSED

Catalog Number 310CRK

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2023

Event Type  Injury  

Event Description

According to the facility on (b)(6) 2023 during a circumcision procedure "tiny shards of metal were left over from the circlamp bell on the remaining foreskin and were removed with forceps and saline wash".

Manufacturer Narrative

According to the facility on (b)(6) 2023 during a circumcision procedure "tiny shards of metal were left over from the circlamp bell on the remaining foreskin and were removed with forceps and saline wash." per the facility the shards were "just lying on the skin and were not embedded".Per the facility they verified "that the patient was not harmed." no additional information is available at this time.The sample is not available for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, 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/1.1CM BELL ST- REPROCESSED
• Manufacturer (Section D): CENTURION; 301 catrell dr; howell MI 48843 1703
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16435787
• MDR Text Key: 310194927
• Report Number: 1824619-2023-00001
• 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: 02/24/2023

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: Health Professional
• Device Catalogue Number: 310CRK
• Device Lot Number: 2022032301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 02/24/2023
• 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