MAUDE Adverse Event Report: HOLGER ULLRICH MAGNUS TABLE COLUMN, MOBILE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001C0

Device Problem Use of Device Problem (1670)

Patient Problems Crushing Injury (1797); Edema (1820); Hematuria (2558)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A service technician visited the clinic and tried to reproduce the described issue.It was not possible to reproduce it.The stability of the table was checked and found to be ok.No play and no foreign objects under the table base were detected.The ground on which the table was placed was level.Further investigation is still ongoing at the date of this report.Once the investigation is finished, we will provide a follow-up / final report.(b)(4)-maquet provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

It was reported that a doctor stuck his foot under the table during a surgery.The table crushed on the doctors foot and hurt his right toe.The following injuries were reported: lesion and bursting of the soft parts with hematoma and edema.Analgesics were administered.Manufacturer reference # (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of of the legal manufacturer of the device maquet gmbh, kehler strasse 31, rastatt, germany 76437.Exemption # e2018004.Getinge usa sales, llc, 45 barbour pond drive, wayne, nj 07470, contact person: (b)(4).This issue was further investigated and it was found that or table collided with an instrument table that was blocking the or tables downward movement.The or table top was lowered further and this resulted in the table base of the or table being lifted from the ground.Once the instrument table slipped out or was removed the table base crashed down and injured the doctors foot.In the instructions for use (ifu) the user is warned concerning the risks related to collisions and advised to ensure that the table does not collide with any obstacles when it is adjusted.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Manufacturer reference # (b)(4).

• Brand Name: MAGNUS TABLE COLUMN, MOBILE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 8428404
• MDR Text Key: 139067861
• Report Number: 8010652-2019-00012
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 118001C0
• Device Catalogue Number: 118001C0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other