MAUDE Adverse Event Report: ESTECH HERCULES ARM

Model Number 401-152

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

The plastic bearing washer was found to be broken.One of the balls and some fragment of the bearing plate were missing.He will take pt x-ray tomorrow, (b)(6) 2014.

• Brand Name: HERCULES ARM
• Type of Device: HERCULES ARM
• Manufacturer (Section D): ESTECH; san ramon CA
• Manufacturer Contact: 2603 camino ramon; suite 100; san ramon, CA 94583 ; 9258667111
• MDR Report Key: 3831976
• MDR Text Key: 20972762
• Report Number: 2953686-2014-00004
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401-152
• Device Catalogue Number: 401-152
• Device Lot Number: 71165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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