MAUDE Adverse Event Report: FINE SURGICAL INSTRUMENTS GOMCO STYLE CIRCUMCISION CLAMP

Catalog Number 50-5611

Device Problem Difficult to Open or Close (2921)

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

Event Date 08/08/2014

Event Type  malfunction  

Event Description

Customer reported that the clamps were not closing all the way.

Manufacturer Narrative

Customer reported the circumcision clamps contained in this tray "would not close all the way." it was reported that the actual device would be returned for evaluation, however, a representative sample was returned.This sample was forwarded to the manufacturer for further investigation which is pending as of the date of this report.The customer reported this same issue as two occurrences; the two circumcision clamps with the same reported issue were from two different manufacturers.

• Brand Name: GOMCO STYLE CIRCUMCISION CLAMP
• Type of Device: GOMCO STYLE CIRCUMCISION CLAMP
• Manufacturer (Section D): FINE SURGICAL INSTRUMENTS; 741 peninsula blvd.; hempstead NY 11550
• Manufacturer (Section G): FINE SURGICAL INSTRUMENTS; 741 peninsula blvd.; hempstead NY 11550
• Manufacturer Contact: sharon cook ; 200 debusk lane; powell, TN 37849 ; 8659387828
• MDR Report Key: 4445152
• MDR Text Key: 16086593
• Report Number: 2320762-2014-00020
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2014

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: 50-5611
• Device Lot Number: 36114886
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/22/2014
• 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