MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS MEDLINE INDUSTRIES, INC.; GOMCO CLAMP 1.45CM

Model Number	DYND04197
Health Effect - Clinical Code	Genital Bleeding (4507)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the circumcision device would not screw down far enough during a circumcision to prevent the penis from bleeding.The doctor stated that he screwed the device down as tight as he could, and when he removed the device the penis bled.Pressure had to be applied and the doctor put a surgical absorbable hemostat on the area to control the bleeding.There was no additional medical intervention required and the baby was reportedly doing fine.Un-used samples were returned to the manufacturer for evaluation it was determined that the facility was disassembling and sterilizing the device in an autoclave prior to use against manufacturer instructions.No additional information is available.Due to the reported incident and 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
It was reported that the circumcision device would not screw down far enough during a circumcision to prevent the penis from bleeding.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: GOMCO CLAMP 1.45CM
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 301 catrell dr; howell MI 48843
• MDR Report Key: 10704646
• Report Number: 1824619-2020-00009
• Device Sequence Number: 11689633
• Product Code: HFX
• UDI-Device Identifier: 10889942395415
• UDI-Public: 10889942395415
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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 Model Number: DYND04197
• Device Catalogue Number: DYND04197
• Device Lot Number: 2020050490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 DA