ULTRASONIC GENERATOR 230V CE
Report
- Report Number
- 9680825-2019-00003
- Event Type
- Malfunction
- Date Received
- January 16, 2019
- Date of Event
- December 28, 2018
- Report Date
- February 12, 2019
- Manufacturer
- ORTHOFIX SRL
- Product Code
- JDX
- PMA / PMN Number
- K093805
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
ON JULY 2017 ORTHOFIX SRL ACQUIRED FROM ORTHOSONICS LTD, THE OSCAR SYSTEM, FOR ULTRASONIC ARTHROPLASTY REVISION. THEREFORE, ORTHOFIX SRL IS NOW MANAGING POST-MARKET SURVEILLANCE FOR OSCAR DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY ORTHOSONICS LTD. THE DEVICES INVOLVED IN THIS EVENT WERE MANUFACTURED BY ORTHOSONICS LTD. TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON JANUARY 17, 2019, WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. ALL DEVICES WERE SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL CHECK EVIDENCED AS FOLLOWS: THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER 3G086, DID NOT SHOW ANY ANOMALIES (MFR REPORT 9680825-2019-00003). ONE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 SERIAL NUMBER 3H0190, SHOWED THAT THE REAR END CAP AND THE SILICONE O-RING WERE NOT IN THEIR PROPER POSITION (MFR REPORT 9680825-2019-00008). THE FUNCTIONAL CHECK EVIDENCED AS FOLLOWS: THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(4) IS FUNCTIONING PROPERLY. THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0190, IS NOT FUNCTIONING PROPERLY. THE SEALING IS LOST FROM THE REAR BODY SEAL. THE GENERATOR SHOWS THE ALERT MESSAGE: "POOR FEEDBACK". THE HANDSET IS NOT DETECTED BY THE GENERATOR. THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER 3G086 IS FUNCTIONING PROPERLY. THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0190, IS MOST LIKELY ATTRIBUTABLE TO WATER THAT ENTERED INSIDE THE HANDSET DURING CLEANING AND STERILIZATION CYCLES. THIS OCCURRED AS A RESULT OF AN UNFORESEEN DISASSEMBLY OF THE CONNECTOR END CAP DURING REPROCESSING. THE SILICONE O-RINGS WAS THEREFORE NOT IN CONTACT WITH THE MATING PARTS HENCE NOT PROVIDING NECESSARY SEALING. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. "I NOTE THAT IN THIS CASE THE OSCAR GENERATOR FUNCTIONED SUFFICIENTLY WELL FOR THE OPERATION TO BE COMPLETED AS PLANNED, BUT EXTRA TIME WAS REQUIRED. THE FINDINGS OF THE TECHNICAL ANALYSIS ARE THAT THE OSCAR GENERATOR IS IN COMPLETE WORKING ORDER WITH NO FAULTS OR SIGNS OF DAMAGE. THE RETURNED CEMENT REMOVAL HANDSET SHOWS A PROBLEM: THE CONNECTOR END CAP HAS BEEN LOOSENED, SO THAT THE JOINT IS VISIBLY OPEN AND THE O-RING WILL NO LONGER PROVIDE A SEAL. I NOTE THAT THE CONCLUSION OF THE TECHNICAL REPORT IS THAT THE HANDSET FAILED BECAUSE THE CONNECTOR END CAP HAS BEEN LOOSENED AT SOME STAGE DURING THE SERVICING PROCESS. THE FAILURE OF THIS JOINT SHOULD HAVE BEEN NOTICED ON INSPECTION AFTER CLEANING. I NOTE THAT IN THE INSTRUCTIONS FOR USE LEAFLET, RE: PQ OSC, THERE ARE CLEAR INSTRUCTIONS THAT THE CONNECTOR END CAP MUST NOT BE REMOVED". FINAL COMMENTS: ON JULY 2017 ORTHOFIX SRL ACQUIRED FROM ORTHOSONICS LTD, THE OSCAR SYSTEM, FOR ULTRASONIC ARTHROPLASTY REVISION. THEREFORE, ORTHOFIX SRL IS NOW MANAGING POST-MARKET SURVEILLANCE FOR OSCAR DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY ORTHOSONICS LTD. THE DEVICES INVOLVED IN THIS EVENT WERE MANUFACTURED BY ORTHOSONICS LTD. THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(4) IS FUNCTIONING PROPERLY. THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0190, IS MOST LIKELY ATTRIBUTABLE TO WATER THAT ENTERED INSIDE THE HANDSET DURING CLEANING AND STERILIZATION CYCLES. THIS OCCURRED AS A RESULT OF AN UNFORESEEN DISASSEMBLY OF THE CONNECTOR END CAP DURING REPROCESSING. THE SILICONE O-RINGS WAS THEREFORE NOT IN CONTACT WITH THE MATING PARTS HENCE NOT PROVIDING NECESSARY SEALING. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: "I NOTE THAT IN THIS CASE THE OSCAR GENERATOR FUNCTIONED SUFFICIENTLY WELL FOR THE OPERATION TO BE COMPLETED AS PLANNED, BUT EXTRA TIME WAS REQUIRED. THE FINDINGS OF THE TECHNICAL ANALYSIS ARE THAT THE OSCAR GENERATOR IS IN COMPLETE WORKING ORDER WITH NO FAULTS OR SIGNS OF DAMAGE. THE RETURNED CEMENT REMOVAL HANDSET SHOWS A PROBLEM: THE CONNECTOR END CAP HAS BEEN LOOSENED, SO THAT THE JOINT IS VISIBLY OPEN AND THE O-RING WILL NO LONGER PROVIDE A SEAL. I NOTE THAT THE CONCLUSION OF THE TECHNICAL REPORT IS THAT THE HANDSET FAILED BECAUSE THE CONNECTOR END CAP HAS BEEN LOOSENED AT SOME STAGE DURING THE SERVICING PROCESS. THE FAILURE OF THIS JOINT SHOULD HAVE BEEN NOTICED ON INSPECTION AFTER CLEANING. I NOTE THAT IN THE INSTRUCTIONS FOR USE LEAFLET, RE: PQ OSC, THERE ARE CLEAR INSTRUCTIONS THAT THE CONNECTOR END CAP MUST NOT BE REMOVED". BASED ON THE RESULTS OF THE TECHNICAL EVALUATION, WHICH CONFIRMED THE ULTRASONIC GENERATOR CONFORMITY, AN ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS DUE TO AN INCORRECT REPROCESSING OF THE HANDSET. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2019-00008.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: MR (B)(6). DATE OF SURGERY: NO RESPONSE. BODY PART TO WHICH DEVICE WAS APPLIED: HIP. SURGERY DESCRIPTION: REVISION SURGERY FOR THE HIP. PATIENT INFORMATION: N.A. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "POOR FREQUENCY CONNECTION ERROR MESSAGE. RECENTLY MOVED TO SINGLE USE PROBES. USED DEVICE FOR REVISION SURGERY OF THE HIP, SINGLE USE PROBE ATTACHED BY EXPERIENCED ODP... POOR FREQUENCY ERROR ON CONSOLE. WE TRIED BOTH PORTS AND BOTH HAND PIECES. SAME ISSUE OCCURRED". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS TO PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (EXTRA ANAESTHETIC, LONGER SURGICAL TIME). AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE XRAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITIONS: NA. NOTE AND COMMENTS: NO PATIENT INFORMATION IS RELEVANT FOR THIS DOCUMENT. ON JANUARY 3, 2019, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS: DATE OF SURGERY WAS FRIDAY (B)(6) 2018. THE EXTRA TIME WAS APPROXIMATELY 3045 MINUTES. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).
ON JULY 2017 ORTHOFIX SRL ACQUIRED FROM ORTHOSONICS LTD, THE OSCAR SYSTEM, FOR ULTRASONIC ARTHROPLASTY REVISION. THEREFORE, ORTHOFIX SRL IS NOW MANAGING POST-MARKET SURVEILLANCE FOR OSCAR DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY ORTHOSONICS LTD. THE DEVICE INVOLVED IN THIS EVENT WAS MANUFACTURED BY ORTHOSONICS LTD. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MEDICAL EVALUATION: THE INFORMATION AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: MR (B)(6); DATE OF SURGERY: NO RESPONSE; BODY PART TO WHICH DEVICE WAS APPLIED: HIP; SURGERY DESCRIPTION: REVISION SURGERY FOR THE HIP PATIENT INFORMATION: N.A. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "POOR FREQUENCY CONNECTION ERROR MESSAGE. RECENTLY MOVED TO SINGLE USE PROBES. USED DEVICE FOR REVISION SURGERY OF THE HIP, SINGLE USE PROBE ATTACHED BY EXPERIENCED ODP... POOR FREQUENCY ERROR ON CONSOLE. WE TRIED BOTH PORTS AND BOTH HAND PIECES. SAME ISSUE OCCURRED". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS TO PATIENT; THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL; PROCEDURE (EXTRA ANAESTHETIC, LONGER SURGICAL TIME); AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITIONS: NA; NOTE AND COMMENTS: NO PATIENT INFORMATION IS RELEVANT FOR THIS DOCUMENT. ON (B)(4) 2019, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS: DATE OF SURGERY WAS FRIDAY (B)(6) 2018. THE EXTRA TIME WAS APPROXIMATELY 30-45 MINUTES. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45464 | ULTRASONIC GENERATOR 230V CE | ULTRASONIC GENERATOR 230V CE | JDX | ORTHOFIX SRL | OS3000 | 3G086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |