LYSONIX E-GN3000 SYSTEM GENERATOR WITH A E-BS220 CANNULA
Report
- Report Number
- 2435119-2017-00001
- Event Type
- Malfunction
- Date Received
- February 6, 2017
- Date of Event
- November 21, 2016
- Report Date
- February 1, 2017
- Manufacturer
- MISONIX INC.
- Product Code
- MUU
- PMA / PMN Number
- K041058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
NOTE THAT (B)(4) IS THE LABELER/DISTRIBUTOR AND MISONIX IS THE SPECIFICATION DEVELOPER/MANUFACTURER. ON 12/19/2016 MISONIX RECEIVED A COMPLAINT REPORT FROM (B)(4) THAT "THE UNIT SHOULD HAVE GONE INTO DEFAULT WHEN THE CANNULA TIP BROKE OFF[?]IT SHOULD HAVE NOT KEPT RUNNING". (B)(4) STATED THE EVENT OCCURRED ON (B)(6) 2016. (B)(4) INFORMED MISONIX THEY ARE FILING AND MDR. NO OTHER INFORMATION ON THE EVENT, INCLUDING INFORMATION TO IDENTIFY THE PATIENT, RELEVANT TESTS AND LABORATORY DATA, PATIENT CLINICAL HISTORY, THE MEDICAL PROCEDURE BEING PERFORMED, OR CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES WERE REPORTED TO MISONIX. SINCE THE LYSONIX 3000 IS A LIPOPLASTY SUCTION SYSTEM, AND THE CANNULA IS DESIGNED FOR LIPOPLASTY, MISONIX CONCLUDES THE MEDICAL PROCEDURE BEING PERFORMED DURING THE EVENT IS MOST PROBABLY LIPOPLASTY. (B)(4) ADVISED MISONIX THAT THE SURGEON INVOLVED WAS NOT RETURNING THE STERILE DISPOSABLE CANNULA OR THE SUBJECT ULTRASONIC SURGICAL GENERATOR FOR EVALUATION. (B)(4) REPORTED THE GENERATOR SERIAL NUMBER TO MISONIX AS (B)(4), MANUFACTURED IN 2003. (B)(4) DID NOT REPORT A CANNULA PART NUMBER OR LOT NUMBER TO MISONIX. MISONIX SUBSEQUENTLY SEARCHED THE MAUDE DATABASE FOR THE MDR FILED BY (B)(4) AND DETERMINED THE MISONIX PART NUMBER FROM THAT MDR. REFER TO MDR# 1645337-2016-00237. THE (B)(4) PART NUMBER, DESCRIPTION AND LOT NUMBER IN THE MDR IS: (B)(4) PART NUMBER OF 3000 M-220BTS: 2 MM DIAMETER AND 20 CM LENGTH MICRO CANNULA. LOT NUMBER A00425-08. THE CORRESPONDING MISONIX PART NUMBER, DESCRIPTION AND LOT NUMBER IS: E-BS220 2 MM X 20 MM BULLET TIP SOLID CANNULA. LOT NUMBER A00425-08. AN EVALUATION OF THE CANNULA TIP AND GENERATOR INVOLVED IN THE EVENT WERE NOT POSSIBLE. (B)(4) STATED THE SURGEON AND INSTITUTION WERE NOT RETURNING EITHER THE CANNULA TIP OR GENERATOR SUBJECT OF THIS COMPLAINT/MDR TO MISONIX. AN EVALUATION OF THE DEVICE IS NOT FEASIBLE. MISONIX INC. IS FILING THIS MANUFACTURER'S MDR IN ACCORDANCE WITH STATUTORY REQUIREMENTS BASED ON THE (B)(4) COMPLAINT AND MDR. (B)(4) DID NOT REPORT A DEATH OR SERIOUS INJURY. SUBSEQUENTLY, MISONIX SEARCHED THE MAUDE DATABASE FOR THE 11/21/2016 EVENT REPORTED BY (B)(4) TO FDA. REFER TO MDR# 1645337-2016-00237. THE EVENT TYPE LISTED IN THE SUBJECT MDR IS AN INJURY. THE EVENT DESCRIPTION STATES: CANNULA TIP BROKE INSIDE THE PATIENT DURING SURGERY. MD REPORTED THE INCIDENT DID NOT CAUSE ANY INJURY TO THE PATIENT. THE LYSONIX 3000 IS A LIPOPLASTY SUCTION SYSTEM. THE USER DID NOT REPORT THAT THE BROKEN TIP NECESSITATES ADDITIONAL MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. ULTRASONIC TIPS CAN BREAK UNDER EXCESSIVE USE CONDITIONS; E.G. WHEN USED FOR EXTENDED DURATION IN TIGHT CAVITIES WITH LIMITED LATERAL MOTION. WHEN A TIP BREAKS, THE FAILURE MODE IS A FRACTURE INTO TWO OR MORE FRAGMENTS WITH THE MAIN PIECE REMAINING IN THE HANDPIECE. THE FAILURE MODE IS NOT SHATTERING INTO SMALL, DIFFICULT TO FIND PIECES. THE FRACTURED PIECES ARE EASILY RETRIEVABLE IMMEDIATELY FROM THE SURGICAL SITE. SURGICAL SUITES ARE EQUIPPED WITH DIAGNOSTIC IMAGING THAT CAN BE USED TO CONFIRM THAT THE FRACTURED PIECES HAVE BEEN REMOVED FROM THE SURGICAL SITE. THEREFORE, THE POTENTIAL RISK FOR SERIOUS INJURY IS EXTREMELY REMOTE. PROBES MAY FRACTURE IF THERE IS METAL TO METAL CONTACT WITH OTHER DEVICES BEING USED IN THE SURGICAL FIELD DURING LIPOPLASTY SUCH AS METAL RETRACTORS. SINCE THE PROBE WAS NOT RETURNED TO MISONIX FOR EVALUATION, MISONIX CANNOT DETERMINE IF THE CHARACTERISTIC VISUAL INDICATORS OF METAL TO METAL CONTACT WERE PRESENT TO RULE OUT THIS AS A ROOT CAUSE. THE IFU INCLUDES THE FOLLOWING WARNING: CARE MUST BE TAKEN NOT TO DAMAGE THE PROBE. DO NOT GOUGE, NICK, SCRATCH, BEND OR KINK PROBES DURING USE OR CLEANING/STERILIZING. DISCARD ANY PROBES WHICH SHOW SIGNS OF SUCH DAMAGE. SINCE THE PROBE WAS NOT RETURNED TO MISONIX FOR EVALUATION, MISONIX CANNOT DETERMINE IF CHARACTERISTIC VISUAL INDICATORS OF EXCESSIVE USE DAMAGE WERE PRESENT TO RULE DAMAGE OUT AS A ROOT CAUSE. THE POTENTIAL FOR DELAY IN SURGERY FOR A PERIOD OF TIME THAT WOULD CAUSE SERIOUS INJURY IS ALSO EXTREMELY REMOTE. THE INSTRUCTIONS FOR USE MANUAL HAS THE FOLLOWING WARNING: SINCE THE LYSONIX 3000® WITH PULSE SELECT¿ IS INTENDED TO BE USED IN VARIOUS TYPES OF INVASIVE SURGERY PROCEDURES, THERE MAY BE INDIRECT DANGER TO THE PATIENT SHOULD THE UNIT FAIL DURING THE PROCEDURE. THEREFORE, IT IS RECOMMENDED THAT A COMPLETE SPARE SYSTEM BE AVAILABLE FOR USE AS A BACKUP. IT IS ROUTINE PRACTICE TO HAVE SPARE PROBES PRESENT IN THE SURGICAL SUITE. THE USER DID NOT REPORT DELAY IN SURGERY AS A CONCERN. SINCE THE USER DID NOT REPORT A SERIOUS INJURY, ADDITIONAL MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE A SERIOUS INJURY, OR DELAY IN SURGERY MISONIX CONCLUDES THE PROPER CLASSIFICATION OF THE EVENT TYPE IS A MALFUNCTION. THE LOT NUMBER INDICATES THE PRODUCT WAS MANUFACTURED IN 2008. THE LAST SHIPMENT OF E-BS220 FROM MISONIX TO (B)(4) WAS MADE ON 12/30/2013. THE CANNULA HAS BEEN IN USE FOR AT LEAST OVER THREE (3) YEARS BASED ON THE LAST SALE DATE OF THIS PART NUMBER TO (B)(4), AND AT WORST CASE USED FOR OVER EIGHT (8) YEARS BASED ON THE MANUFACTURING DATE. THE INSTRUCTION FOR USE MANUAL, LYSONIX 3000 WITH PULSE SELECT OPERATION MANUAL, E5000AML30_B, INDICATES THE LIFE CYCLE OF ALL PROBES TO BE >200 CYCLES. HOWEVER, A NOTATION IS MADE THAT: THE REUSE LIFE GIVEN TAKES INTO ACCOUNT WEAR AND TEAR DUE TO CLEANING AND STERILIZATION ONLY. DAMAGE OR WEAR CAUSED BY ACTUAL USE IN SURGERY WILL AFFECT LIFE OF COMPONENTS. FURTHERMORE, THE IFU STATES THAT: THE WARRANTY PERIOD FOR THE LYSONIX ULTRASONIC SURGICAL SYSTEM COMPONENTS ARE AS FOLLOWS: ULTRASONIC PROBES: SIX MONTHS FROM DATE OF SHIPMENT (THESE DISPOSABLE COMPONENTS ARE WARRANTED AGAINST DEFECTS IN WORKMANSHIP FOR THEIR USEFUL LIFE). THEREFORE, THE DEVICE WAS USED AFTER ITS WARRANTY AND THERE IS HIGH PROBABILITY THE PROBE WAS USED WELL IN EXCESS OF THE RECOMMENDED USABLE LIFE OF 200 CLEANING AND STERILIZATION CYCLES. (B)(4) REPORTED TO MISONIX AS PART OF THIS COMPLAINT THAT, IN THE SURGEON'S OPINION, THE GENERATOR SHOULD NOT HAVE REMAINED RUNNING WHEN THE TIP BROKE. THE GENERATOR IS DESIGNED WITH A MECHANICAL LIMIT FAULT ALARM THAT INCLUDES BOTH AN INDICATOR LITE AND AUDIBLE ALARM. AT A PRESET THRESHOLD FREQUENCY, THE UNIT INDICATES A MECHANICAL LIMIT FAULT. THE UNIT IS NOT DESIGNED TO SHUT OFF WHEN A MECHANICAL LIMIT FAULT OCCURS. IN ADDITION, WHEN A PROBE FRACTURES, IT MAY DO SO IN A MANNER THAT THE THRESHOLD FREQUENCY TOLERANCE IS NOT BREACHED. NOT ALL INCIDENTS OF A PROBE FRACTURE WILL CAUSE A MECHANICAL LIMIT FAULT. THEREFORE, SURGEON'S COMPLAINT THAT THE UNIT SHOULD HAVE SHUT OFF IS INCORRECT AND NOT A MALFUNCTION. TREND ANALYSIS WAS PERFORMED JANUARY 17, 2017 AND INCLUDED A REVIEW OF COMPLAINT FILES FROM JANUARY 1, 2014 TO DECEMBER 31, 2016. THE TREND DATA INDICATES THE FOLLOWING: NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THE SUSPECT CANNULA TIP E-4100ASO22 AND/OR FOR LOT # A00435-08. ONE (1) COMPLAINT OF A BROKEN PROBE WAS RECEIVED ON ANOTHER LYSONIX 3000 PROBE PART NUMBER. THEREFORE, FOR THE TREND TIME PERIOD THERE ARE TWO (2) COMPLAINTS OF BROKEN PROBES FOR ALL PART NUMBERS SOLD TO (B)(4). THERE ARE SIX (6) ADDITIONAL PART NUMBERS OF LYSONIX 3000 PROBES MANUFACTURED BY MISONIX FOR A TOTAL OF SEVEN (7) PARTS. TWO HUNDRED AND SIXTY (260) PROBES OF ALL PART NUMBERS WERE SOLD TO (B)(4) DURING THE TREND TIME PERIOD. (B)(4). THE PARTS ARE REUSABLE. MISONIX CANNOT ESTIMATE THE COMPLAINT RATE BY THE ACTUAL AREA OF OPPORTUNITY DEFINED AS COMPLAINT RATE VS. THE NUMBER OF PROCEDURES PERFORMED DURING THE TREND TIME PERIOD BECAUSE THE CUSTOMER BASE IS (B)(4) CUSTOMERS, AND MISONIX DOES NOT HAVE ACCESS TO THE ACTUAL CUSTOMERS OR DATA ON HOW MANY PROCEDURES A CUSTOMER PERFORMS REUSING A GIVEN PROBE. MISONIX BELIEVES IT IS REASONABLE TO ASSUME THE COMPLAINT RATE BY THE AREA OF OPPORTUNITY (PROCEDURES) IS ONE (1) OR TWO (2) LOGS LESS THAN THE RATE BY UNITS SOLD.. DEVICE NOT RETURNED.
ON 12/19/2016 MISONIX RECEIVED A COMPLAINT REPORT FROM (B)(4) THAT "THE UNIT SHOULD HAVE GONE INTO DEFAULT WHEN THE CANNULA TIP BROKE OFF SHOULD HAVE NOT KEPT RUNNING". (B)(4) STATED THE EVENT OCCURRED ON (B)(6) 2016. NOTE THAT (B)(4) IS THE LABELER/DISTRIBUTOR AND MISONIX IS THE SPECIFICATION DEVELOPER/MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88670 | LYSONIX E-GN3000 SYSTEM GENERATOR WITH A E-BS220 CANNULA | ULTRASOUND ASSISTED LIPOPLASTY SYSTEM | MUU | MISONIX INC. | E-GN 3000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |