RADIAL SETTING CLAMP
Received Jul 21, 2021 · Event occurred Jul 15, 2021
Report 8010652-2021-00025 · MDR key 12201879
Device
Generic name
Table And Attachments, Operating-room
Manufacturer
Holger UllrichModel number
100323C0Catalog number
100323C0
Product problems
- Unintended Movement
- Unintended Movement
Patient
Not reported
- Numbness
- Unspecified Tissue Injury
- Insufficient Information
- Numbness
- Unspecified Tissue Injury
- Insufficient Information
Narrative
Additional 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.
Description of Event or Problem
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).
Additional 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.
Description of Event or Problem
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).