MAUDE Adverse Event Report: MOGEN CLAMP

Catalog Number DGI 47-505

Device Problem Malposition of Device (2616)

Patient Problem Tissue Damage (2104)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

During an elective circumcision procedure, the distal portion of the glans penis was inadvertently partially amputated.The event was discovered immediately and the patient underwent penile tissue reattachment in operating room with good results.Preliminary investigation indicated that more than usual non-conspicuous jaw gap in mogen clamp might have contributed to this event.

• Brand Name: MOGEN CLAMP
• Type of Device: MOGEN CLAMP
• MDR Report Key: 3960960
• MDR Text Key: 4560924
• Report Number: MW5037420
• Device Sequence Number: 1
• Product Code: HFX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DGI 47-505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 DA