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

Model Number	310CR
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Circlamp removed foreskin without the use of scalpel, required sutures to stop bleeding.
Additional Manufacturer Narrative
Updating conclusion code to include 143 - quality control deficiency and 23 - manufacturing deficiency.

• Brand Name: CENTURION CIRCLAMP
• Common Device Name: CIRCUMCISION CLAMP
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston MI 48895
• MDR Report Key: 9633164
• Report Number: 1824619-2020-00001
• Device Sequence Number: 3141648
• Product Code: HFX
• UDI-Device Identifier: 00653160197471
• UDI-Public: (01)00653160197471(10)2019061801(17)240331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K890897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 310CR
• Device Lot Number: 2019061801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3008403546-08-26-2019/01
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention