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

Model Number 10033700

Device Problems Crack (1135); Detachment of Device or Device Component (2907); Unintended Movement (3026)

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

Event Date 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : third party service inspection.

Event Description

On 26th february 2024, getinge became aware of an issue with one of our accessories - (b)(6) - screw tension device used with 141901jc - extension device.As it was stated and confirmed with the photographic evidence, cracks in screw fixing parts of the housing were discovered.On (b)(6) 2024, additional information was provided.It has been confirmed that the issue occurred during hip joint displacement surgery on an anesthetized patient.As it was stated, the accessory detached completely leading to slow change in patient position that was under staff control.The issue resulted in a delay in procedure.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the detachment of the accessory leading to change in the patient position and delay in surgery resulting in prolonged anesthesia time, were to reoccur.

• Brand Name: SCREW TENSION 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: 19048417
• MDR Text Key: 339574061
• Report Number: 8010652-2024-00049
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: JO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10033700
• Device Catalogue Number: 10033700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 141901JC - EXTENSION DEVICE