MAUDE Adverse Event Report: MOGEN CLAMP; CLAMP, CIRCUMCISION

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2020

Event Type  malfunction  

Event Description

Prior to performing circumcision on patient, neonatal nurse practitioner (nnp) tested mogen clamp by opening, closing, and locking clamp without any issues.During circumcision, nnp was able to fully close the mogen on the patient's foreskin but was unable to lock clamp into place.When nnp opened the mogen, the foreskin was severed so she was able to reclose the mogen and remove the foreskin without any complications.Mogen was discarded.

• Brand Name: MOGEN CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• MDR Report Key: 12007887
• MDR Text Key: 256545470
• Report Number: 12007887
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA