MAUDE Adverse Event Report: CAREFUSION MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN; CLAMP, CIRCUMCISION

Model Number GL7021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Physical Entrapment (2327)

Event Date 09/21/2014

Event Type  Injury  

Event Description

The tip of the penis was amputated and had to be re-attached.The tip got caught in the clamp.The customer stated she didn't have a reason to believe the instrument malfunctioned.Additional information was obtained from the customer.The event happened on (b)(6) 2014.Following the circumcision, the baby was transported to (b)(6) hospital along with the preserved tip of the penis.They do not believe that the instrument malfunctioned.They will not return the instrument to carefusion.The hospital will not be releasing the clamp due to possible litigation with the father of the baby.

Manufacturer Narrative

(b)(4).The customer indicated the device is not available for return.If the device shall become available, or if additional information is provided, an evaluation will be performed.

Manufacturer Narrative

(b)(4).The customer indicated that the complaint samples are not available for evaluation.The hospital will not be releasing the clamp due to possible litigation with the father of the baby.Since the complaint samples are not available, an evaluation could not be performed and root cause could not be determined.This device is currently manufactured by one of carefusion¿s approved third party suppliers.Since the lot number is unknown, it could not be confirmed if the current or previous supplier manufactured this specific device.However, the current supplier confirmed that these devices are 100% inspected prior to final release.A review of the carefusion complaint system was performed for this instrument over the last 12 months ((b)(6) 2013-(b)(6) 2014).There have been no other reported complaints of any kind for this instrument.The complaint will be reopened and an evaluation will be performed by carefusion should the complaint sample become available.

• Brand Name: MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4167322
• MDR Text Key: 21241001
• Report Number: 1423507-2014-00023
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: GL7021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 DA
• Patient Weight: 2