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

Model Number STB-30C4S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2018

Event Type  malfunction  

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 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
• Type of Device: STABILIZER, HEART
• Manufacturer (Section D): KDL MEDICAL DBA CHASE MEDICAL; 885 e. collins blvd.,; suite, 110; richardson,
• Manufacturer (Section G): KDL MEDICAL DBA CHASE MEDICAL; 885 e. collins blvd.,; suite 110; richardson 75081
• Manufacturer Contact: jackie lafollette ; 885 e. collins blvd.,; suite 110; richardson 75081 ; 9727837005
• MDR Report Key: 7327181
• MDR Text Key: 102322656
• Report Number: 1649139-2018-00002
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00899054002449
• UDI-Public: 899054002449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C024062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1