MAUDE Adverse Event Report: HOLGER ULLRICH RADIAL SETTING CLAMP; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100323C0

Device Problem Unintended Movement (3026)

Patient Problems Numbness (2415); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The following was reported to us.The radial setting clamp was used to mount the leg supports (100586b0) to the or table.During the procedure the clamp became loose and the left leg fell down with the leg support.The patient was injured due to this.The extent of the patients injury is unknown.Manufacturer reference # (b)(4).

Manufacturer Narrative

The affected clamp was investigated by a getinge-maquet member.No damages or signs of wear were found on the affected clamp.Therefore we assume that this issue occurred due to a use error.We assume that the clamp was either not tightened properly when the leg holder was mounted to it or it was accidentally loosened during the surgery.In the instructions for use (ifu) the user is warned concerning the risks related to lose or loosened securing elements as follows: "[.]warning! risk of injury! products / accessories not attached properly may loosen and cause injuries.Ensure that products / accessories are mounted correctly and that the securing elements (handle screws, catches, levers, etc.) are closed and firmly tightened, also ensure that moving parts are correctly secured.[.]" in the ifu it is described how accessories can be mounted to the radial setting clamp.The user is told in the ifu to tighten the tommy screw firmly and to check the proper seating afterwards.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

We have received the following information concerning the patients injury and outcome: after the surgery the patient described a stabbing pain in his lower back and a numb feeling in the right leg.The patient could not lift his right leg.The patient was examined in the clinic and got some pain relief.The pain decreased with the help of this analgetic.He was able to use his leg as before and had normal sensivity.He was able to go home on the 16th of july.Manufacturer reference # (b)(4).

• Brand Name: RADIAL SETTING CLAMP
• 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: 12201879
• MDR Text Key: 262619206
• Report Number: 8010652-2021-00025
• 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: 09/29/2021

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: 100323C0
• Device Catalogue Number: 100323C0
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 09/29/2021
• Patient Sequence Number: 1
• Treatment: LEG HOLDER 100586B0; LEG HOLDER 100586B0
• Patient Outcome(s): Other