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

Model Number 100380A0

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

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.(b)(6).

Event Description

On 21st february 2024, getinge became aware of an issue with one of our accessories - 100380a0 - leg holder.As it was stated, all four pan head screws on the shoe joint taping of the leg holder were found to be missing on the right side.Boot securing plate had become detached from assembly when the staff picked the device to move it.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the use of a leg holder with missing screws during surgery which could result in unintended change in patient position or patient's fall, 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: 18844184
• MDR Text Key: 337153587
• Report Number: 8010652-2024-00033
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 03/06/2024

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 Model Number: 100380A0
• Device Catalogue Number: 100380A0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1