MAUDE Adverse Event Report: ESTECH HERCULES ARM

Model Number 401-152

Device Problem Break (1069)

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

Event Date 01/21/2014

Event Type  malfunction  

Event Description

Tuesday, (b)(6) 2014 while performing a procedure with dr (b)(6), he asked for the estech hercules heart holder 2 finger short to help support the heart in a helpful orientation.When he began to tighten the instrument to make it rigid, the tightening cable broke which caused all the individual pieces of the hercules to fall into the open chest.A x-ray was taken at the conclusion of the case to rule out any retained pieces.X-ray film was cleared by attending radiologist (b)(6).Surgical attending notified of results.

• Brand Name: HERCULES ARM
• Type of Device: HERCULES ARM
• Manufacturer (Section D): ESTECH; san ramon CA
• Manufacturer Contact: 2603 camino ramon; ste 100; san ramon, CA 94583 ; 9258667111
• MDR Report Key: 3823840
• MDR Text Key: 4390120
• Report Number: 2953686-2014-00003
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401-152
• Device Catalogue Number: 401-152
• Device Lot Number: 71022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention