MAUDE Adverse Event Report: MAQUET GMBH EXTENSION DEVICE; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 141901HC

Device Problems Break (1069); Positioning Failure (1158)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1h event site postal code: (b)(6).H3 other text : device not returned to manufacturer.

Event Description

On 3rd august 2022 getinge became aware of an issue with one of our devices - 141901hc - extension device.As it was stated, the locking bolt on the left side snapped off when the surgeon was locking down the position.On 1st december 2023, additional information was received.It was confirmed that the malfunction occurred during patient positioning.The table was replaced with another one to continue the procedure.The issue led to a delay of minimum 15 minutes.According to the provided information, the patient was most likely already anesthetized when the incident occurred.Upon examination of the affected device, left tension block was found to be damaged leading to inability to fully lock and unlock.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.

Manufacturer Narrative

Getinge became aware of an issue with one of our devices - 141901hc - extension device used with 143302f0 yuno ii mobile operating table.As it was stated, the locking bolt on the left side snapped off when the surgeon was locking down the position.Recently, additional information was received.It was confirmed that the malfunction occurred during patient positioning.The table was replaced with another one to continue the procedure.The issue led to a delay of a minimum 15 minutes.According to the provided information, the patient was most likely already anesthetized when the incident occurred.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, 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 the malfunction of the device was confirmed, it has been assessed that the getinge device failed to meet its specifications.A review of the received customer product complaints revealed that in the past the issues did not lead to serious injury to the user.The issue is a single and isolated case.The customer has sent the affected getinge device for in-house service repair.There, it has been evaluated by the company¿s service technician.The device was received incomplete.The customer sent only the tension block assembly.Upon examination of the affected device, the left tension block was found to be damaged leading to the inability to fully lock and unlock.A tension block (component number 31139734) and cap (component number 86009194) were replaced.The tension block was cleaned and the old grease was removed.The technician applied new grease and tested the functionality and range of motion.The device was tested positive and released to usage.The service technician at the repair center was contacted to obtain additional information regarding the repair.It has been assessed that the tension screw was physically damaged.The technician stated that it possibly collided with something or dropped.In the instructions for use (ifu 1419.01 en 32, page 19), the user is warned that, when adjusting and moving the or table, the transporter, the table top or the accessories, as well as when carrying out a table top transfer, collisions may occur between the patient and individual products or parts that are pointing downwards.During adjustments, the user shall observe the or table, the transporter, the table top and accessories constantly and avoid collisions.The user is also informed (ifu 1419.01 en 32, page 19), that whenever the product is mounted and adjusted, there is a danger of pinching and shearing to the accessories.The user shall always ensure that the accessories do not collide with any nearby objects.It is likely that the user utilized the device disregarding the safety notes from the instructions for use.In summary and as a result of the performed root cause evaluation, it was concluded that the investigated issue was most likely caused by the user error.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, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 3rd august 2022 getinge became aware of an issue with one of our devices - 141901hc - extension device.As it was stated, the locking bolt on the left side snapped off when the surgeon was locking down the position.On (b)(6) 2023, additional information was received.It was confirmed that the malfunction occurred during patient positioning.The table was replaced with another one to continue the procedure.The issue led to a delay of minimum 15 minutes.According to the provided information, the patient was most likely already anesthetized when the incident occurred.Upon examination of the affected device, left tension block was found to be damaged leading to inability to fully lock and unlock.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Corrected b5 describe event or problem: on 3rd august 2022, getinge became aware of an issue with one of our devices - 141901hc - extension device used with 143302f0 - yuno ii mobile operating table.As it was stated, the locking bolt on the left side snapped off when the surgeon was locking down the position.On 1st december 2023, additional information was received.It was confirmed that the malfunction occurred during patient positioning.The table was replaced with another one to continue the procedure.The issue led to a delay of a minimum 15 minutes.According to the provided information, the patient was most likely already anesthetized when the incident occurred.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.

Event Description

On 3rd august 2022, getinge became aware of an issue with one of our devices - 141901hc - extension device used with 143302f0 - yuno ii mobile operating table.As it was stated, the locking bolt on the left side snapped off when the surgeon was locking down the position.On 1st december 2023, additional information was received.It was confirmed that the malfunction occurred during patient positioning.The table was replaced with another one to continue the procedure.The issue led to a delay of a minimum 15 minutes.According to the provided information, the patient was most likely already anesthetized when the incident occurred.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.

• Brand Name: EXTENSION DEVICE
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• 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: 18308450
• MDR Text Key: 330260726
• Report Number: 8010652-2023-00136
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 141901HC
• Device Catalogue Number: 141901HC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 143302F0 YUNO 2 US WITH AUTODRIVE.