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

Model Number 100586B0

Device Problems Break (1069); 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.Event site name (e1): (b)(6) hospital.H3 other text : device not returned to manufacturer.

Event Description

On 4th july 2023 getinge became aware of an issue with one of our accessories ¿ 100586b0 - leg holder, pair.As it was stated and confirmed with the photographic evidence, the connection between leg holder frame and pneumatic spring was broken during the operation.The issue led to interruption of the surgery as no support was given for the patient's leg.The affected device was replaced and surgery was completed on another leg holder.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely fast unintended movement of leg holder boot which could potentially lead to nerve damage with lasting harm, was to reoccur.

• Brand Name: LEG HOLDER, PAIR
• 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: 17442482
• MDR Text Key: 320240793
• Report Number: 8010652-2023-00071
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 100586B0
• Device Catalogue Number: 100586B0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1