MAUDE Adverse Event Report: MAQUET GMBH MEERA EU WITH AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 720001B2

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problem Limb Fracture (4518)

Event Date 10/13/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 getinge became aware of an incident with one of our mobile tables - 720001b2 - meera eu with auto drive.As it was stated, the following situation took place during laparoscopic cholecystectomy.The table was in reverse trendelenburg positon for about 10 minutes.The ports had been placed about 15 minutes earlier.At this point, a change in the positon of the table into right side up was requested by the surgeon and it was initiated by "left" button on the remote control.Immediately after the button was pushed the entire table jolted downward to the left resulting in surgeon collapsing to the floor as his foot got caught under the table.One of the nurses was able to pull the surgeon's foot from under the table.Following an incident an x-ray was performed confirming fracture of toe of the user.According to the provided information, at the time of incident the table had been in the locked position and a mayo stand was under or beside the end of the table as well as a bear hugger device which got smashed.We decided to report the issue due to the serious injury of the user.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.

Manufacturer Narrative

We would like to provide the correction of initially provided information.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event or problem and h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 13th october 2023 getinge became aware of an incident with one of our mobile tables - 720001b2 - meera eu with auto drive.As it was stated, the following situation took place during laparoscopic cholecystectomy.The table was in reverse trendelenburg position for about 10 minutes.The ports had been placed about 15 minutes earlier.At this point, a change in the position of the table into right side up was requested by the surgeon and it was initiated by "left" button on the remote control.Immediately after the button was pushed the entire table jolted downward to the left resulting in surgeon collapsing to the floor as his foot got caught under the table.One of the nurses was able to pull the surgeon's foot from under the table.Following an incident an x-ray was performed confirming fracture of toe of the user.According to the provided information, at the time of incident the table had been in the locked position and a mayo stand was under or beside the end of the table as well as a bear hugger device which got smashed.We decided to report the issue due to the serious injury of the user.Corrected b5 describe event or problem: on 13th october 2023 getinge became aware of an incident with one of our mobile tables - 720001b2 - meera eu with auto drive.As it was stated, the following situation took place during laparoscopic cholecystectomy.The table was in reverse trendelenburg position for about 10 minutes.The ports had been placed about 15 minutes earlier.At this point, a change in the position of the table into right side up was requested by the surgeon and it was initiated by "left" button on the remote control.Immediately after the button was pushed the entire table jolted downward to the left resulting in surgeon collapsing to the floor as his foot got caught under the table.The patient also jolted to the left but was strapped in.One of the nurses was able to pull the surgeon's foot from under the table.Following an incident an x-ray was performed confirming fracture of toe of the user.The patient did not suffer any injury.According to the provided information, at the time of incident the table had been in the locked position and a mayo stand was under or beside the end of the table as well as a bear hugger device which got smashed.We decided to report the issue due to the serious injury of the user and potential for serious injury of the patient if the situation, namely the fast unintended movement of the table during laparoscopic cholecystectomy, was to reoccur.Previous h6 medical device ¿ problem code: insufficient information|||3190 corrected h6 medical device ¿ problem code: mechanical problem|unintended movement||3026.

Event Description

On 13th october 2023 getinge became aware of an incident with one of our mobile tables - 720001b2 - meera eu with auto drive.As it was stated, the following situation took place during laparoscopic cholecystectomy.The table was in reverse trendelenburg positon for about 10 minutes.The ports had been placed about 15 minutes earlier.At this point, a change in the positon of the table into right side up was requested by the surgeon and it was initiated by "left" button on the remote control.Immediately after the button was pushed the entire table jolted downward to the left resulting in surgeon collapsing to the floor as his foot got caught under the table.The patient also jolted to the left but was strapped in.One of the nurses was able to pull the surgeon's foot from under the table.Following an incident an x-ray was performed confirming fracture of toe of the user.The patient did not suffer any injury.According to the provided information, at the time of incident the table had been in the locked position and a mayo stand was under or beside the end of the table as well as a bear hugger device which got smashed.We decided to report the issue due to the serious injury of the user and potential for serious injury of the patient if the situation, namely the fast unintended movement of the table during laparoscopic cholecystectomy, was to reoccur.

• Brand Name: MEERA EU WITH AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 17971269
• MDR Text Key: 326127356
• Report Number: 3013876692-2023-00050
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 720001B2
• Device Catalogue Number: 720001B2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2024
• Distributor Facility Aware Date: 02/15/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2024
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male