MAUDE Adverse Event Report: SURGICAL DESIGN CIRCUMCISION CLAMP

Catalog Number 50-5613

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

Hospital reported circumcision clamps are not closing all the way.

Manufacturer Narrative

Customer reported that circumcision clamps (contained inside the tray) are not closing all the way.Device was reported as available for return.The device manufacturer has been notified and returned samples will be provided for their investigation.No injuries to the patient were reported.

• Brand Name: CIRCUMCISION CLAMP
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): SURGICAL DESIGN; 7351-d lockport place; lorton VA 22079 000
• Manufacturer (Section G): SURGICAL DESIGN; 7351-d lockport place; lorton VA 22079 000
• Manufacturer Contact: sharon cook ; 200 debusk ln; powell, TN 37849-0000 ; 8653626157
• MDR Report Key: 4202678
• MDR Text Key: 4961166
• Report Number: 3006851902-2014-00002
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2014

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: Health Professional
• Device Catalogue Number: 50-5613
• Device Lot Number: 34729561
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other