MAUDE Adverse Event Report: OASYS HEALTHCARE SPRING ARM

Model Number SM-OA91-3AS-A

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

New replacement covers were sent to the facility and these have been installed onto the spring arm.Complaint #: (b)(4).

Event Description

One of the covers between the extension arm and spring arm manufactured by oasys) which support the amico ice 30 light fell down during surgery.

• Brand Name: SPRING ARM
• Type of Device: SPRING ARM
• Manufacturer (Section D): OASYS HEALTHCARE; 191 main st n; uxbridge, on L9P 1 C3
• Manufacturer Contact: agustin de paredes ; 55 east wilmot street; richmond hill, on L4B 1-A3 ; 7640800
• MDR Report Key: 5200343
• MDR Text Key: 30496945
• Report Number: 3007682310-2015-00001
• Device Sequence Number: 1
• Product Code: KQM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SM-OA91-3AS-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1