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

Model Number 100586B0

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).At the time of this report the investigation was still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.

Event Description

It was reported that there was an incident with a leg holder.This resulted in the patient's foot to be injured.Further details regarding this event were requested, but are not yet available at the date of this report.(b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet gmbh.(b)(4).Exemption # e2018004.(b)(4).A getinge-maquet service technician visited the customer and investigated the product in question.No malfunction or defect could be found.The user stated that the device has moved during operation.The described movements can be released by opening a locking handle.In the instructions for use (ifu) the user is told to ensure that the leg holder is properly seated after adjusting it.Furhter the user is warned concerning the risks related to loose or loosened securing elements.Quote ifu: "risk of injury! loose or loosened securing elements may cause injuries.When applying, and after every adjustment process, tighten all securing elements of the product firmly (handle screws, catches, levers, etc.).Check the firm seating of the securing elements." since no malfunction or damage could be found we assume that the locking handle was eather not tightened properly or accidently released.The customer refused to provide further information concerning the patient status.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The product was investigated by a getinge maquet service technician and no malfunction or damage was found.Manufacturer reference # (b)(4).

• Brand Name: LEG HOLDER, PAIR
• 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: 8412495
• MDR Text Key: 138537330
• Report Number: 8010652-2019-00011
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

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: 100586B0
• Device Catalogue Number: 100586B0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other