MAUDE Adverse Event Report: HOLGER ULLRICH YUNO 2 EU WITH AUTODRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 143302B0

Device Problems Device Difficult to Setup or Prepare (1487); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 04/22/2020

Event Type  Injury  

Manufacturer Narrative

The device is manufactured by maquet gmbh.Maquet medical systems is the importer of this device.A follow-up importer medical device report will be submitted once the results from the manufacturer are available.

Event Description

An accessory called "traction bar with ball joint" (1007.40a0) can be mounted and detached from the operating table.While mounting this accessory a staff member injured the tip of a finger.A surgery was required to repair the tip of the finger.Manufacturer reference # (b)(4).

Event Description

Manufacturer reference # 321645.

Manufacturer Narrative

The potentially affected products (100740a0 - traction bar with ball joint) were investigated by a getinge-maquet service engineer.There are two products 100740a0 in the clinic.Their serial numbers are (b)(6).The user could not tell, which of these was involved in the incident.The traction device with serial number 130 was not fully releasing.This makes it more difficult to attache the device to the talble.The traction device with serial number 46 could be attached and detachted from/to the table easily.In the instructions for use (ifu) the user is warned as follows concerning the use of defective devices: "warning! risk of injury! faulty or defective products may result in injuries.Before use, check the proper working order and fully functional state of the product.Stop using faulty or defective products and inform the getinge representative." the injured user could not remember where his hand was, when the incident occurred.The risk of crashing and shearing hazards is inherent due to the size and weight of the product.In the ifu for 100740a0 the user is warned concerning these risk as follows: "warning! risk of injury! whenever the product is mounted and adjusted, there is a danger of pinching and shearing to the staff, patient and accessories.Always ensure that no one can be subjected to pinching or shearing action or injured in any other way and that the accessories do not collide with any nearby objects." the complaints database was reviewed concerning similar issues with 100740a0 or the yuno ii tables (143302xx).No similar issues were reported to us.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: YUNO 2 EU WITH AUTODRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 10091555
• MDR Text Key: 192209690
• Report Number: 3013876692-2020-00025
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 143302B0
• Device Catalogue Number: 143302B0
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2020
• Distributor Facility Aware Date: 10/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 100740A0 TRACTION BAR WITH BALL JOINT; 100740A0 TRACTION BAR WITH BALL JOINT
• Patient Outcome(s): Required Intervention