MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U (DV); SURGICAL TABLE

Model Number 1723633

Device Problems Intermittent Continuity (1121); Unintended Movement (3026)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

The table was evaluated by a trumpf medical technician.During device inspection by a field service technician a damaged column cladding was identified.Currently it is unclear if this damage was a result of the alleged dropping.No other defect or malfunction of the device was noticed.If further information will become available during further investigation a follow-up report will be submitted.

Event Description

The customer alleged the operating table dropped about 3-4 inches during a surgical procedure with a patient on the device.No injury was reported.This report was filed in our complaint handling system as complaint # (b)(4).

Event Description

The customer alleged the operating table dropped about 3-4 inches during a surgical procedure with a patient on the device.No injury was reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

During further investigation of the event, especially the log files, it was identified that the device did not malfunction.The most likely cause for the event is a collision with a foreign equipment during trendelenburg or anti-trendelenburg movement.The damaged column cladding was also most likely caused by this collision.According to the user manual the user must observe all movements of the device to ensure no collision will occur.Based on this no further action is required.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U (DV)
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 11699333
• MDR Text Key: 250241974
• Report Number: 3007143268-2021-00006
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00887761989719
• UDI-Public: 887761989719
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1723633
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1