MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG OP-TISCH SATURN SELECT 3.03; SURGICAL TABLE

Model Number 1522236

Device Problem Device Fell (4014)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

It was reported that the leg section got lose without unlocking the locking mechanism of the coupling point.The leg section had fallen down and almost hit the feets of a or-staff employee.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

Inspection of the device is pending.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.

Manufacturer Narrative

The device was inspected by a field service technician.It could be reproduced that the leg section could be removed from the tabletop without an active opening of the locking pin.When wobbling at the leg section the locking pin opened by itself and allowed the leg section to separate from the tabletop.It was identified that the plain bearing bush inside the tabletop had significant wear which caused an increased clearance within the coupling point (tabletop ¿ leg section).Additionally, the pin of the leg section which connects into the bearing of the tabletop had a visual damage (notch).This had an influence to the locking pin which secures the leg section within the tabletop.After replacing of the identified defect parts the leg section was securely attached to the tabletop and could not be removed unintentionally, only by an active opening of the locking pin.The ifu requires a check of the correct fixation of the leg section at the tabletop and that all parts are undamaged and in a good working order prior to the use.The alleged deficiency was likely to be detected prior use.According to the ifu a maintenance interval of one year is defined.The surgical table and leg section was not maintained by the legal manufacturer.The customer was trained for those service procedures and is executing repairs and maintenance under own responsibility.Based on these findings and as there is no significant trend of this failure mode, no further actions are required.

Event Description

It was reported that the leg section got lose without unlocking the locking mechanism of the coupling point.The leg section had fallen down and almost hit the feets of a or-staff employee.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: OP-TISCH SATURN SELECT 3.03
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 15892337
• MDR Text Key: 306891344
• Report Number: 3007143268-2022-00029
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00887761988323
• UDI-Public: 887761988323
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1522236
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1