MAUDE Adverse Event Report: RYCOR; RYCOR HAND TABLE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

Event Description

Hand table purchased (b)(6) 2021.In march the mounting bracket broke on one side replacement part was sent in at no charge.On (b)(6) the bracket broke again this time both sides.

• Type of Device: RYCOR HAND TABLE
• Manufacturer (Section D): RYCOR; 2053 atwater dr.; north port FL 34288
• MDR Report Key: 12266780
• MDR Text Key: 264915786
• Report Number: 12266780
• Device Sequence Number: 1
• Product Code: JEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1