VAPR CLPLSE90 ELECTRODE W HAND CNTRLS
Report
- Report Number
- 1221934-2021-02191
- Event Type
- Injury
- Date Received
- July 13, 2021
- Report Date
- June 30, 2021
- Manufacturer
- DEPUY MITEK LLC US
- Product Code
- GEI
- PMA / PMN Number
- K113545
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE BRAND NAME AND LOT NUMBER WERE REPORTED AS UNKNOWN ON THE INITIAL REPORT; THEREFORE, THE COMMON DEVICE NAME, PROCODE, UDI, EXPIRATION DATE, AND 510(K) HAVE BEEN UPDATED ACCORDINGLY. UDI: (01)10886705010097(10)U2009110(17)230831
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: H4: THE DEVICE MANUFACTURE DATE WAS REPORTED AS UNKNOWN ON THE INITIAL REPORT; AND HAS BEEN UPDATED ACCORDINGLY. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED IN LABORATORY. VISUAL INSPECTION REVEALED THAT THE CABLE IS IN GOOD CONDITION AS WELL AS THE CONNECTOR AND PINS. THE SUCTION TUBE SHOWS SALINE RESIDUES, AND NO ANOMALIES COULD BE IDENTIFIED ON THE TIP. ALSO, IT WAS IDENTIFIED SOME MARKS IN THE BLACK COATING OF THE SHAFT. THE ELECTRODE WAS SENT TO THE MANUFACTURER FOR FURTHER TESTING. THE VAPR CLPLSE90 ELECTRODE W HAND CNTRLS WAS RETURNED TO MANUFACTURER FOR EVALUATION. THE MANUFACTURER CONDUCTED VISUAL INSPECTION AND FUNCTIONAL TEST OF DEVICE RECEIVED BY CUSTOMER. UPON VISUAL INSPECTION THE DEVICE WAS NOT RETURNED IN THE ORIGINAL PACKAGING. THE DEVICE IS IN A USED CONDITION WITH TISSUE DEBRIS IN AND AROUND THE ACTIVE TIP, PROCEDURAL RESIDUE VISIBLE DOWN THE FULL LENGTH OF THE SUCTION TUBE. FINALLY, NO VISIBLE DAMAGE TO THE HANDLE, CABLE OR PLUG. TO CONFIRM THE LOCATION OF THE BLOCKAGE, A THIN GAUGE WIRE WAS INSERTED INTO THE SUCTION TUBE UNTIL THE BLOCKAGE WAS REACHED. A DHR REVIEW HAS BEEN PERFORMED FOR THE COMPLAINT DEVICE LOT NUMBER U2009110; NO ISSUES (NCRS OR DEVIATIONS) WITH THE MANUFACTURING PROCESS HAVE BEEN INDICATED WHICH MIGHT EXPLAIN THE FAILURES OBSERVED. BASED ON A REVIEW OF THE INVESTIGATION FINDINGS AND PRODUCT RA NO CONTAINMENT OR CORRECTION ACTION RELATED TO THE INDIVIDUAL COMPLAINT IS REQUIRED. THE DEVICE SUCCESSFULLY PASSED ALL THE ELECTRICAL TESTS AND ACTIVATED AS EXPECTED ON BOTH ABLATE AND COAG MODES. THE FLOW TESTS DID HIGHLIGHT A RESTRICTION IN THE SUCTION PATH THAT PREVENTED THE DEVICE ACHIEVING THE FLOW SPECIFICATION. THE ROOT CAUSE OF THE SUCTION ISSUE WAS FOUND TO BE A PARTIAL BLOCKAGE LOCATED AT THE DISTAL END OF THE ACTIVE SUCTION TUBE WHICH HAS BEEN CAUSED BY PROCEDURAL TISSUE DEBRIS BECOMING STUCK IN THE SUCTION PATH. THE PURPOSE OF THE SUCTION FUNCTION IS TO ASSIST IN THE REMOVAL OF BUBBLES AND DEBRIS CREATED DURING ACTIVATION WITHIN THE OPERATING SITE. IF THE SUCTION FLOW BECOMES BLOCKED AND THE BLOCKAGE UNNOTICED BY THE USER, OVERHEATING OF FLUID MAY OCCUR WHICH COULD CAUSE A THERMAL INJURY. OTHER THAN PROCEDURAL TISSUE/DEBRIS BLOCKING THE SUCTION PATH FROM THERE IS NO EVIDENCE TO SUGGEST THAT THERE WAS A FAULT WITH RETURNED COMPLAINT DEVICE. AS A SERIOUS INJURY WAS REPORTED CAPA-200167 WAS RAISED IN THE OISTE-UK QMS SYSTEM TO REVIEW THE EVENT. AS PER IFU, ENSURE THAT FLUID INFLOW AND OUTFLOW IS ADEQUATE AND THAT THE ELECTRODE IS ACTIVATED ONLY WHEN SURROUNDED BY CONDUCTIVE IRRIGATE SOLUTION. INSERT THE ELECTRODE INTO A FLUID-FILLED JOINT SPACE THROUGH A PREPARED ENTRY POINT. THE USE OF RF ENERGY WITH INADEQUATE IRRIGATION MAY OVERHEAT THE FLUID ENOUGH TO CAUSE SKIN BURNS AT OR NEAR THE ACCESS SITE AND MAY RESULT IN DAMAGE TO THE ELECTRODE TIP ASSEMBLY REDUCE SUCTION WHEN DEVICE IS NOT IN USE. INSERT THE ELECTRODE INTO A FLUID-FILLED JOINT SPACE THROUGH A PREPARED ENTRY POINT. ENSURE THAT THE ELECTRODE IS SURROUNDED BY CONDUCTIVE IRRIGATE SOLUTION WHEN IN USE. AT THIS POINT IN TIME, IN DEPUY SYNTHES MITEK, ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS RETAINED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. SHOULD THE DEVICE EVER BE RECEIVED BACK IN THE FUTURE, THIS COMPLAINT FILE WILL BE REOPENED AT THAT TIME AND AN EVALUATION WILL BE PERFORMED AND DOCUMENTED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS REPORT IS FOR AN UNKNOWN ELECTRODE. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER, 510-K NUMBER AND MANUFACTURING SITE NAME ARE UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FLUID LEAKING FROM THE JOINT WAS SO HOT THAT IT BURNED THE PATIENT'S SKIN. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1053013 | VAPR CLPLSE90 ELECTRODE W HAND CNTRLS | ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE | GEI | DEPUY MITEK LLC US | U2009110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |