MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION CIRCLAMP; CIRCUMCISION CLAMP

Model Number 310CR

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

A recall associated with this lot had already been initiated prior to the receipt of this complaint.Our records indicate the user was notified on 8/28/2019 and the user subsequently reported they had no inventory remaining from this lot on (b)(6) 2019.Per the complaint report, the device associated with this report was used in (b)(6) 2019.

Event Description

Circlamp removed foreskin without the use of scalpel, required sutures to stop bleeding.

Manufacturer Narrative

Updating conclusion code to include 143 - quality control deficiency and 23 - manufacturing deficiency.

• Brand Name: CENTURION CIRCLAMP
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston MI 48895
• MDR Report Key: 9633164
• MDR Text Key: 177338561
• Report Number: 1824619-2020-00001
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 00653160197471
• UDI-Public: (01)00653160197471(10)2019061801(17)240331
• Combination Product (y/n): N
• PMA/PMN Number: K890897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 310CR
• Device Lot Number: 2019061801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3008403546-08-26-2019/01
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention