MAUDE Adverse Event Report: HOLGER ULLRICH HEAD PLATE; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 113067B0

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.When the investigation is completed the report will be updated and a follow up medwatch will be submitted.

Event Description

The following was reported.The device was laying on the floor.When a cleaning staff member picked it up after the surgery, she pinched her finger.The joints of the head plate moved and the right hand middle finger got caught.To free the caught finger, the head plate was mounted to the or tabletop.The affected area was ice packed and the injured member got pain reliever.No injury to the bone occurred.Manufacturer reference # (b)(4).

Manufacturer Narrative

The affected device was investigated by a getinge field service engineer (fse).The fse did not find any damage or malfunction on the head plate.We assume that a use error contributed to this injury.The user is warned as follows in the instructions for use (ifu) concerning crushing and shearing hazards: "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." getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Further information concerning where the finger was pinched on the product and how the medical outcome of this injury was, was requested from the clinic.This information was not provided by the clinic.Manufacturer reference (b)(4).

• Brand Name: HEAD PLATE
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 11654335
• MDR Text Key: 245079749
• Report Number: 8010652-2021-00017
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 113067B0
• Device Catalogue Number: 113067B0
• Device Lot Number: N/A
• Date Manufacturer Received: 10/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR