MAUDE Adverse Event Report: DORNIER MEDTECH SYSTEMS GMBH CYSTO TABLE; TABLE, CYSTOMETRIC, NON-ELECTRIC AND ACCESSORIES

Model Number GENESIS R

Device Problems No Display/Image (1183); Protective Measures Problem (3015); Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

Cysto table imaging stopped working during procedure & table would not move.Error message of "foot pedal faulty" received.Faulty positioning foot pedal diagnosed.Able to control w/hand controls, but if foot pedal was used imaging & ability to move table lost.Fda safety report id #(b)(4).

• Brand Name: CYSTO TABLE
• Type of Device: TABLE, CYSTOMETRIC, NON-ELECTRIC AND ACCESSORIES
• Manufacturer (Section D): DORNIER MEDTECH SYSTEMS GMBH
• MDR Report Key: 15265911
• MDR Text Key: 298457580
• Report Number: MW5111624
• Device Sequence Number: 1
• Product Code: KQS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GENESIS R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male