MAUDE Adverse Event Report: MAQUET GMBH MOTOR DRIVEN JOINT-MODULE - PERINEAL; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118011B0

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 5th january 2023 getinge became aware of an incident with one of our devices ¿ 118011b0 - motor driven joint-module - perineal.As it was stated, the patient fell on surgeon's legs.Additional details regarding the incident were requested, however, no information was received to date.We decided to report the issue based on the potential for serious injury if the situation, namely the patient falling off the table, was to reoccur.

Manufacturer Narrative

Getinge became aware of an incident with one of our devices ¿ 118011b0 ¿ motor-driven joint-module - perineal used with the basis table top with catalog number 118010a0.As it was reported, the patient fell on the surgeon's legs.Additionally, it has been stated that during tilting the plate, the patient was not secured by straps.The event happened during the surgical procedure (digestive surgery) when the patient was under anesthesia.The patient was not harmed, but the incident led to 30 minutes delay of the surgical operation, as the patient had to be repositioned.We decided to report the issue based on the potential for serious injury if the situation, namely the patient falling on the surgeon's legs leading to the prolonged anesthesia time, was to reoccur.The getinge technician visited the hospital and examined the affected device and other devices involved in the incident.No technical malfunctions of the devices were discovered.According to the provided information, the patient could have fallen, because the accessories were not used properly.The technician reported that the accessories were misadjusted due to improper selection of accessories for the type of medical procedure.Additionally, the technician clarified that the joint module was used with a rigid plate of the universal padded with catalog number 118011a1 and a cushion 90933962 from padded plate for urological interventions.The rigid plate used was too short for the cushion and thus has not provided sufficient support at the level of buttocks.With the information gathered as a result of the root cause analysis performed, we conclude that the reported issue was caused by user error related to not following instructions given in user manual.In the user manual (1180.11 en 06, page 17) the user is warned that the patient can slip off the or table if sfc padding are not properly secured on the modules due to insufficient clamping.The user is warned to only attach pads to the module that have been authorized for the module.The user is also warned that if the patient is not secured, particularly when adjusting/moving, the patient and/or their extremities may slip in an uncontrolled manner, therefore the user always ought to secure the patient using suitable aids (e.G.Straps) and maintain continuous observation (1180.11 en 06, page 15).With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, thus was also directly involved with the reported incident.As no actual malfunctions were found it was considered that the getinge device was up to specification.The situation is considered as single and isolated per a review performed as part of the investigation.There was no similar complaint found related to this issue failure pattern as described in this event, therefore the failure ratio for the configuration of the devices is 0,007% for the issue investigated herein.We currently do not have any information that would warrant 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.The correction of b5 describe event or problem and h4 device manufacture date fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 5th january 2023 getinge became aware of an incident with one of our devices ¿ 118011b0 - motor driven joint-module - perineal.As it was stated, during digestive surgery, the table top was tilted leading to the anesthetized patient slipping from the table top and falling on surgeon's legs.According to the provided information, the patient was not secured with straps at the time of incident.The repositioning of the patient led to a 30 minutes delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the patient falling off the table leading to a delay resulting in prolonged anesthesia, was to reoccur.Corrected b5 describe event or problem: on 5th january 2023, getinge became aware of an incident with one of our devices ¿ 118011b0 ¿ motor-driven joint-module - perineal used with the basis table top with catalog number 118010a0.As it was reported, the patient fell on the surgeon's legs.Additionally, it has been stated that during tilting the plate, the patient was not secured by straps.The event happened during the surgical procedure (digestive surgery) when the patient was under anesthesia.The patient was not harmed, but the incident led to 30 minutes delay of the surgical operation, as the patient had to be repositioned.We decided to report the issue based on the potential for serious injury if the situation, namely the patient fell on the surgeon's legs leading to the prolonged anesthesia time, was to reoccur.Previous h4 device manufacture date: 12/01/2019.Corrected h4 device manufacture date: 12/03/2019.

Event Description

On 5th january 2023, getinge became aware of an incident with one of our devices ¿ 118011b0 ¿ motor-driven joint-module - perineal used with the basis table top with catalog number 118010a0.As it was reported, the patient fell on the surgeon's legs.Additionally, it has been stated that during tilting the plate, the patient was not secured by straps.The event happened during the surgical procedure (digestive surgery) when the patient was under anesthesia.The patient was not harmed, but the incident led to 30 minutes delay of the surgical operation, as the patient had to be repositioned.We decided to report the issue based on the potential for serious injury if the situation, namely the patient fell on the surgeon's legs leading to the prolonged anesthesia time, was to reoccur.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.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, h6 health effect ¿ impact codes and h6 medical device ¿ problem code fields deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 5th january 2023 getinge became aware of an incident with one of our devices ¿ 118011b0 - motor driven joint-module - perineal.As it was stated, the patient fell on surgeon's legs.Additional details regarding the incident were requested, however, no information was received to date.We decided to report the issue based on the potential for serious injury if the situation, namely the patient falling off the table, was to reoccur.Corrected b5 describe event or problem: on 5th january 2023 getinge became aware of an incident with one of our devices ¿ 118011b0 - motor driven joint-module - perineal.As it was stated, during digestive surgery, the table top was tilted leading to the anesthetized patient slipping from the table top and falling on surgeon's legs.According to the provided information, the patient was not secured with straps at the time of incident.The repositioning of the patient led to a 30 minutes delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the patient falling off the table leading to a delay resulting in prolonged anesthesia, was to reoccur.Previous h6 health effect ¿ impact codes: no health consequences or impact|||2199 corrected h6 health effect ¿ impact codes: surgical intervention|prolonged surgery||4632 previous h6 medical device ¿ problem code: insufficient information|||3190 corrected h6 medical device ¿ problem code: use of device problem|||1670.

Event Description

On 5th january 2023, getinge became aware of an incident with one of our devices ¿ 118011b0 - motor driven joint-module - perineal.As it was stated, during digestive surgery, the table top was tilted leading to the anesthetized patient slipping from the table top and falling on surgeon's legs.According to the provided information, the patient was not secured with straps at the time of incident.The repositioning of the patient led to a 30 minutes delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the patient falling off the table leading to a delay resulting in prolonged anesthesia, was to reoccur.

• Brand Name: MOTOR DRIVEN JOINT-MODULE - PERINEAL
• 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: 16325826
• MDR Text Key: 309182703
• Report Number: 8010652-2023-00010
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118011B0
• Device Catalogue Number: 118011B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 118010A0 TAB. TOP 118011A1 PAD 100506A0 LEG HOLDER