LEG HOLDER, PAIR
Received Mar 12, 2019 · Event occurred Mar 1, 2019
Report 8010652-2019-00011 · MDR key 8412495
Device
Generic name
Table And Attachments, Operating-room
Manufacturer
Holger UllrichModel number
100586B0Catalog number
100586B0
Product problems
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
- Use of Device Problem
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (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.
Description of Event or Problem
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).
Additional 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.
Description of Event or Problem
THE PRODUCT WAS INVESTIGATED BY A GETINGE MAQUET SERVICE TECHNICIAN AND NO MALFUNCTION OR DAMAGE WAS FOUND. MANUFACTURER REFERENCE # (B)(4).