RADIAL SETTING CLAMP
Report
- Report Number
- 8010652-2024-00078
- Event Type
- Malfunction
- Date Received
- July 4, 2024
- Report Date
- July 4, 2024
- Manufacturer
- MAQUET GMBH
- Product Code
- BWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. (B)(6).
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100323C0 - RADIAL SETTING CLAMP. AS IT WAS STATED, THE RADIAL SETTING CLAMP SLIPPED LEADING TO QUICK DROP OF A BARIATRIC STIRRUP THAT WAS PLACED IN THE CLAMP. THE INCIDENT OCCURRED WHEN THE PATIENT¿S LEG WAS IN THE BOOT. ACCORDING TO THE CUSTOMER, THE TEETH WERE ALIGNED CORRECTLY, AND THE CLAMP WAS APPROPRIATELY TIGHTENED TO THE STIRRUP POLE, HOWEVER, THE DEVICE STILL DROPPED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, WAS TO REOCCUR. ACCORDING TO INFORMATION PROVIDED BY THE SALES AND SERVICE DEPARTMENT, THE CUSTOMER WAS OFFERED DIFFERENT TYPES OF CLAMPS - NON-ROTARY CLUMP (100322C0) AND TRAINED ON HOW TO USE THEM PROPERLY. BASED ON THE INVESTIGATION CONDUCTED, IT WAS CONCLUDED THAT AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY BEING USED FOR THE PATIENT¿S TREATMENT AND WAS THEREFORE DIRECTLY INVOLVED IN THE REPORTED INCIDENT. AS THE ISSUE OCCURRED, IT WAS CONSIDERED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR INCIDENT OCCURRED. TO ENSURE SAFE OPERATION, VISUAL AND FUNCTIONAL INSPECTIONS MUST BE CONDUCTED BY A TRAINED PERSON PRIOR TO EACH USE. IF CRACKS, DAMAGE TO MECHANICAL PARTS, OR IMPROPER LOCKING MECHANISMS ARE IDENTIFIED, THE DEVICE MUST BE DISCONTINUED IMMEDIATELY. THE IFU INCLUDES A SUGGESTED CHECKLIST FOR THESE INSPECTIONS (GA 1003.23 REV 07, PAGE 16). IF THE PRE-USE CHECK HAD BEEN PERFORMED CORRECTLY, ANY DAMAGED EQUIPMENT SHOULD HAVE BEEN IDENTIFIED. ACCORDING TO THE IFU (GA 1003.23 REV 07, PAGE 17), IF THE DEVICE IS FOUND DAMAGED OR FAILS TO MEET FUNCTIONALITY REQUIREMENTS, IT SHOULD NOT BE USED. THE CUSTOMER CONTINUED TO USE THE AFFECTED DEVICE FOLLOWING THE INCIDENT. THE USER MANUAL PROVIDES DETAILED INSTRUCTIONS ON HANDLING THE DEVICE, INCLUDING PROPER MOUNTING AND ADJUSTMENT PROCEDURES (GA 1003.23 REV 07, PAGES 9-11). SPECIFICALLY, THE INSTRUCTIONS FOR USE HIGHLIGHT A RISK OF LOOSE OR LOOSENED SECURING ELEMENTS, WHICH MAY CAUSE INJURIES. THE USER SHOULD CHECK IF ALL OF THE LOCKING ELEMENTS ARE TIGHTENED PROPERLY (HANDLE SCREW, LOCKS, LEVERS, ETC.) AFTER MOUNTING OR ADJUSTMENT. CHECK THE FIRM SEATING OF THE LOCKING ELEMENTS. (1003.23 REV 07, PAGE 13). THE MAXIMUM LOAD CAPACITY FOR THE PRODUCT IS 34.5 KG (GA 1003.23 REV 07, PAGE 5). IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT BASED ON AVAILABLE INFORMATION THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, IS RELATED TO THE USER ERROR. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION REGARDING DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, H3A DEVICE EVALUATED BY MFG?, H3B DEVICE NOT EVAL PROVIDE CODE, FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION AND THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100323C0 - RADIAL SETTING CLAMP. LATER ON, IT WAS CONFIRMED THAT THE INCIDENT INVOLVING THE PATIENT OCCURRED. AS IT WAS STATED, THE RADIAL SETTING CLAMP SLIPPED LEADING TO QUICK DROP OF A BARIATRIC STIRRUP THAT WAS PLACED IN THE CLAMP. THE INCIDENT OCCURRED WHEN THE PATIENT¿S LEG WAS IN THE BOOT. ACCORDING TO PROVIDED INFORMATION, THE TEETH WERE ALIGNED CORRECTLY AND THE CLAMP WAS APPROPRIATELY TIGHTENED TO THE STIRRUP POLE, HOWEVER, THE DEVICE STILL DROPPED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100323C0 - RADIAL SETTING CLAMP. AS IT WAS STATED, THE RADIAL SETTING CLAMP SLIPPED LEADING TO QUICK DROP OF A BARIATRIC STIRRUP THAT WAS PLACED IN THE CLAMP. THE INCIDENT OCCURRED WHEN THE PATIENT¿S LEG WAS IN THE BOOT. ACCORDING TO THE CUSTOMER, THE TEETH WERE ALIGNED CORRECTLY, AND THE CLAMP WAS APPROPRIATELY TIGHTENED TO THE STIRRUP POLE, HOWEVER, THE DEVICE STILL DROPPED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, WAS TO REOCCUR. PREVIOUS H3A DEVICE EVALUATED BY MFG? NO (ATTACH PAGE TO EXPLAIN WHY NOT OR PROVIDE CODE). CORRECTED H3A DEVICE EVALUATED BY MFG? YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A.
ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE CORRECTION OF AWARE DATE WAS REQUIRED. THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, D4 UNIQUE IDENTIFIER (UDI) AND G3 DATE RECEIVED BY MANUFACTURER DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 11TH JUNE 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100323C0 - RADIAL SETTING CLAMP. ON (B)(6) 2024, IT WAS CONFIRMED THAT THE INCIDENT INVOLVING THE PATIENT OCCURRED. AS IT WAS STATED, THE RADIAL SETTING CLAMP SLIPPED LEADING TO QUICK DROP OF A BARIATRIC STIRRUP THAT WAS PLACED IN THE CLAMP. THE INCIDENT OCCURRED WHEN THE PATIENT¿S LEG WAS IN THE BOOT. ACCORDING TO PROVIDED INFORMATION, THE TEETH WERE ALIGNED CORRECTLY AND THE CLAMP WAS APPROPRIATELY TIGHTENED TO THE STIRRUP POLE, HOWEVER, THE DEVICE STILL DROPPED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100323C0 - RADIAL SETTING CLAMP. LATER ON, IT WAS CONFIRMED THAT THE INCIDENT INVOLVING THE PATIENT OCCURRED. AS IT WAS STATED, THE RADIAL SETTING CLAMP SLIPPED LEADING TO QUICK DROP OF A BARIATRIC STIRRUP THAT WAS PLACED IN THE CLAMP. THE INCIDENT OCCURRED WHEN THE PATIENT¿S LEG WAS IN THE BOOT. ACCORDING TO PROVIDED INFORMATION, THE TEETH WERE ALIGNED CORRECTLY AND THE CLAMP WAS APPROPRIATELY TIGHTENED TO THE STIRRUP POLE, HOWEVER, THE DEVICE STILL DROPPED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, WAS TO REOCCUR. PREVIOUS D4 UNIQUE IDENTIFIER (UDI)#: N/A. CORRECTED D4 UNIQUE IDENTIFIER (UDI)#: (B)(4). PREVIOUS G3 DATE RECEIVED BY MANUFACTURER: 07/01/2024, CORRECTED G3 DATE RECEIVED BY MANUFACTURER 06/28/2024.
ON 11TH JUNE 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100323C0 - RADIAL SETTING CLAMP. ON 1ST JULY 2024, IT WAS CONFIRMED THAT THE INCIDENT INVOLVING THE PATIENT OCCURRED. AS IT WAS STATED, THE RADIAL SETTING CLAMP SLIPPED LEADING TO QUICK DROP OF A BARIATRIC STIRRUP THAT WAS PLACED IN THE CLAMP. THE INCIDENT OCCURRED WHEN THE PATIENT¿S LEG WAS IN THE BOOT. ACCORDING TO PROVIDED INFORMATION, THE TEETH WERE ALIGNED CORRECTLY AND THE CLAMP WAS APPROPRIATELY TIGHTENED TO THE STIRRUP POLE, HOWEVER, THE DEVICE STILL DROPPED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, WAS TO REOCCUR.
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100323C0 - RADIAL SETTING CLAMP. AS IT WAS STATED, THE RADIAL SETTING CLAMP SLIPPED LEADING TO QUICK DROP OF A BARIATRIC STIRRUP THAT WAS PLACED IN THE CLAMP. THE INCIDENT OCCURRED WHEN THE PATIENT¿S LEG WAS IN THE BOOT. ACCORDING TO THE CUSTOMER, THE TEETH WERE ALIGNED CORRECTLY, AND THE CLAMP WAS APPROPRIATELY TIGHTENED TO THE STIRRUP POLE, HOWEVER, THE DEVICE STILL DROPPED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, WAS TO REOCCUR.
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100323C0 - RADIAL SETTING CLAMP. LATER ON, IT WAS CONFIRMED THAT THE INCIDENT INVOLVING THE PATIENT OCCURRED. AS IT WAS STATED, THE RADIAL SETTING CLAMP SLIPPED LEADING TO QUICK DROP OF A BARIATRIC STIRRUP THAT WAS PLACED IN THE CLAMP. THE INCIDENT OCCURRED WHEN THE PATIENT¿S LEG WAS IN THE BOOT. ACCORDING TO PROVIDED INFORMATION, THE TEETH WERE ALIGNED CORRECTLY AND THE CLAMP WAS APPROPRIATELY TIGHTENED TO THE STIRRUP POLE, HOWEVER, THE DEVICE STILL DROPPED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, WAS TO REOCCUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 617278 | RADIAL SETTING CLAMP | TABLE AND ATTACHMENTS, OPERATING-ROOM | BWN | MAQUET GMBH | 100323C0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |