MAUDE Adverse Event Report: SYMMETRY SURGICAL, INC. HEANEY-BALLANTINE FORCEPS

Model Number 19-5505

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/02/2014

Event Type  malfunction  

Event Description

Dr.Said clamp tip was breaking while in use in vagina though uterus was already out of patient.Then she took out clamp and tip that broke off.Instrument used in total vaginal hyst.Device failed (e.G.Broke, could not get it to work or stopped working).Device malfunction: the device did not do what ti was supposed to do.

Manufacturer Narrative

Device was not returned for evaluation.

• Brand Name: HEANEY-BALLANTINE FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): SYMMETRY SURGICAL, INC.; antioch TN 37013
• Manufacturer Contact: chris smith ; 3034 owen dr; antioch, TN 37013
• MDR Report Key: 4232778
• MDR Text Key: 5073393
• Report Number: 3007208013-2014-00015
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 19-5505
• Device Catalogue Number: 19-5505
• Other Device ID Number: 008874820000601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51.0 YR