MAUDE Adverse Event Report: MAQUET GMBH LEG HOLDER; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100380A0

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

On 24th october 2023 getinge became aware of an issue with one of our accessories - 100380a0 - leg holder.As it was stated, the screws on the shoe joint taping of the newly delivered leg holder were missing.The issue was not noticed during handing over to the customer and was discovered by nurses.It has been concluded that it is possible the malfunction will not be detected during pre-use check.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely leg holder with missing screws used during operation which could result in unintended change in patient position or patient's fall, was to occur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1i event site telephone: (b)(6).H3 other text : device not returned to manufacturer.

Event Description

On 24th october 2023, getinge became aware of an issue with one of our accessories - 100380a0 - leg holder.As it was stated, the screws on the shoe joint taping of the newly delivered leg holder were missing.The issue was not noticed during handing over to the customer and was discovered by nurses.It has been concluded that it is possible the malfunction will not be detected during the pre-use check.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the leg holder breaks due to the missing screws and, as a consequence, the leg of the patient will fall down with the result of nerve overstretching, was to occur.

Manufacturer Narrative

Getinge became aware of an issue with one of our accessories - 100380a0 - leg holder.As it was stated, the screws on the shoe joint taping of the newly delivered leg holder were missing.The issue was not noticed during handing over to the customer and was discovered by nurses.It has been concluded that it is possible the malfunction will not be detected during the pre-use check.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the leg holder breaking due to the missing screws, which could lead to the leg of the patient falling down and the result of nerve overstretching, was to occur.With the investigation performed it was concluded that upon the event occurrence, the device was not being used for the patient¿s treatment, however was directly involved with the reported incident.As the screws in the leg holder were missing, it was concluded that the getinge device failed to meet its specification.A review of the received customer product complaints revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.The issue investigated herein is a single and isolated case.The root cause evaluation was performed by the manufacturer due to corrective and preventive actions 2023-016 and related field action.The process assurance department was informed by ssu austria that 4 screws connecting the interface plate to the clamping joint were not fitted to leg holder 100380a0.In addition, the plate was provided with dowel pins, which were fitted.However, as the fits were in the upper tolerance range and the four locking screws were not fitted, the interface plate will detach from the clamping joint as soon as it is loaded.It is possible that the interface plate might have detached from the clamping joint despite successful assembly and final test without load as the four locking screws that connect the interface plate to the clamping joint were missing.This was not noticed during assembly and the final inspection.The screws were missing as the panel is additionally fixed with dowel pins and the screws are covered with a sticker, so in consequence, it was not noticed that the employee had forgotten to fit the screws.It was not noticed as when the material for this production order was provided, the screws were forgotten.It was concluded that the issue was caused by due to human error and insufficient quality inspection during assembly.The manufacturer initiated corrective and preventive actions 2023-016 and related field action to check the devices in the scope of the field action.The customers were informed about the issue via field safety notice.The service technicians were informed to check the devices at the customer sites and perform necessary actions.If missing screws will be detected, the screws will be mounted by a technician.In summary and as a result of the root cause evaluation, it can be concluded that the reported issue, namely the leg holder breaking due to the missing screws, which could lead to the leg of the patient falling down and result of nerve overstretching, was caused by the manufacturing error.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 24th october 2023 getinge became aware of an issue with one of our accessories - 100380a0 - leg holder.As it was stated, the screws on the shoe joint taping of the newly delivered leg holder were missing.The issue was not noticed during handing over to the customer and was discovered by nurses.It has been concluded that it is possible the malfunction will not be detected during pre-use check.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely leg holder with missing screws used during operation which could result in unintended change in patient position or patient's fall, was to occur.Corrected b5 describe event or problem: on 24th october 2023, getinge became aware of an issue with one of our accessories - 100380a0 - leg holder.As it was stated, the screws on the shoe joint taping of the newly delivered leg holder were missing.The issue was not noticed during handing over to the customer and was discovered by nurses.It has been concluded that it is possible the malfunction will not be detected during the pre-use check.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the leg holder breaks due to the missing screws and, as a consequence, the leg of the patient will fall down with the result of nerve overstretching, was to occur.

• Brand Name: LEG HOLDER
• 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: 18190349
• MDR Text Key: 328743795
• Report Number: 8010652-2023-00123
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100380A0
• Device Catalogue Number: 100380A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 05/27/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1