MAUDE Adverse Event Report: KDL MEDICAL DBA CHASE MEDICAL TRIPOD HEART STABILIZER-NYLON FASTRACT; STABILIZER, HEART

Model Number	STB-30C4S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stabilizer was returned in a biohazard bag inside the original shipper box with the label attached.Functional evaluation of the device was performed.The device did not show any defect in this testing.The stabilizer was mounted on a retractor rail.The base locked in place and the stabilizer arm tightened with the handle.The arm held as expected and no defects were found.Chase medical was unable to recreate the failure during functional evaluation.Accordingly, it appears the problem was user error.Review of the lot history record showed nothing out of the ordinary.All testing was performed and documented with no issues seen during the manufacture of the lot.Functional testing upon return of the device could not duplicate the reported failure and the device appeared fully functional.
Event or Problem Description
As described - "arm wouldn't hold on stabilizer during surgery".There was no harm to the patient and they just used another stabilizer.Chase medical was notified of this complaint on (b)(6) 2018 by customer, (b)(6).This incident occurred at (b)(6) general hospital.

• Brand Name: TRIPOD HEART STABILIZER-NYLON FASTRACT
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): KDL MEDICAL DBA CHASE MEDICAL; 885 e. collins blvd.,; suite, 110; richardson,
• MDR Report Key: 7327181
• Report Number: 1649139-2018-00002
• Device Sequence Number: 19136899
• Product Code: MWS
• UDI-Device Identifier: 00899054002449
• UDI-Public: 899054002449
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: C024062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 12/19/2020
• Device Model Number: STB-30C4S
• Device Catalogue Number: STB-30C4S
• Device Lot Number: D712003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1