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.E1b event site name: (b)(6) h3 other text : device not returned to 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 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.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 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.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.

Manufacturer Narrative

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 the "left" button on the remote control.Immediately after the button was pushed the entire table jolted downward to the left resulting in the 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 the incident, an x-ray was performed confirming the fracture of the toe of the user.The patient did not suffer any injury.According to the provided information, at the time of the 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 that got smashed.We decided to report the issue due to the serious injury of the user and the potential for serious injury of the patient if the situation, namely the fast unintended movement of the table during laparoscopic cholecystectomy, was to reoccur.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment and was directly involved with the reported incident.As no malfunction with the device was reported, it has been assessed that the getinge device was up to the specification.A review of the received customer product complaints revealed that the issues led to serious injuries to the users.Comparing the number of complained devices, for the table¿s base falling on the user¿s foot leading to fracture, to the number of meera operating tables placed on the market, we can conclude the failure ratio is (b)(4) as there were six similar reportable customer product complaints to the one investigated herein.Comparing the number of complained devices, for the table¿s base falling on the user¿s foot, leading to fast unintended movement of the patient, to the number of meera operating tables placed on the market, we can conclude the failure ratio is (b)(4).This issue is a single and isolated case.The affected getinge device has been evaluated by the company¿s service technician.The technician inspected the table, downloaded and analyzed error logs.Following the inspection, it has been assessed that the device was up to specification as no malfunction of the device was found.The operating table¿s full function check was done and no errors were reported.As the device was working properly it was released for usage.Based on the provided by the technician photographic evidence and available information, the manufacturer has assessed that 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 bair hugger device which got smashed.As it has been evaluated, by the wrong usage, the table was lying on the bair hugger device.Hence, the table could not move further down and as a consequence, the foot of the operating table was lifted at that side where the bair hugger device was.Eventually, the bair hugger device smashed under the load of the table.At this moment, the surgeon had his foot under the lifted table¿s base which led to the described consequences.It has been concluded that the operator did not comply with the instruction for use (ifu 7200.01 en 11, page 26), which clearly states that the user should always ensure that no one can be subjected to pinching or shearing action or injured in any other way and that the accessories do not collide with any nearby objects during adjusting, moving or storing the or table/table top.In the ifu (ifu 7200.01 en 11, page 28), the user is also warned that when setting down the or table, there is a risk of crushing and shearing to the feet or objects.The user is instructed that before putting down the or table, they shall make sure there are no objects located under the or table base.When lowering the or table, the user shall keep sufficient distance to the or table base.In summary, based on all available information it has been established that the root cause of the investigated issue was most likely related to the user error.In our evaluation the information we currently hold does not warrant any further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.

Event Description

Manufacturer's reference number (b)(4).

• 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: 17962959
• MDR Text Key: 326005177
• Report Number: 8010652-2023-00112
• 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: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2023

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
• 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