MAUDE Adverse Event Report: AESCULAP AG & CO. KG HEART XS MEDIAN RETRACTOR ONLY; CARDIAC RETRACTOR FOR MIN INVASIVE

Model Number FC137R

Device Problem Retraction Problem (1536)

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

Event Date 02/07/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Retractor was not movable intraoperative and had to be removed rigid from the patient.No interference to the patient.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: there is visible material fretting in the area of the drive.The manufacturing and quality documentation has been checked and found to be according to the specifications valid at the time of production.There are no indications for a material or manufacturing defect.The excessively strong material wear is caused by insufficient oiling and cleaning.No further actions required.

• Brand Name: HEART XS MEDIAN RETRACTOR ONLY
• Type of Device: CARDIAC RETRACTOR FOR MIN INVASIVE
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen 7853 2; DA 78532
• Manufacturer (Section G): AESCULAP AG&GO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3810473
• MDR Text Key: 4372479
• Report Number: 2916714-2014-00237
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FC137R
• Device Catalogue Number: FC137R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other