ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2014-00167
- Event Type
- Injury
- Date Received
- September 17, 2014
- Report Date
- August 13, 2014
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- PMA / PMN Number
- K083330
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
PMA/510(K) #: K083330 (K934356). INFO RECEIVED INDICATED THE NURSE WAS CUT WHILE TRYING TO REMOVE THE STYLET FROM THE DEVICE DURING THE PROCEDURE. CUT HAS BEEN DESCRIBED AS A PAPERCUT. CLINICAL OPINION RECEIVED INDICATED THAT ANY TIME THERE IS EXPOSURE TO BODILY FLUIDS, IT WOULD BE CONSIDERED LIFE THREATENING. THIS DETERMINATION COULD CHANGE IF THE NURSE TESTED NEGATIVE FOR HIV ETC FOLLOWING THE INCIDENT. IT MAY BE NOTED THAT THE NURSE'S TESTS WERE RECEIVED NEGATIVE. ADOPTING A CONSERVATIVE APPROACH, THIS MATTER WILL STILL BE SUBMITTED AS A SERIOUS INJURY MDR. THIS IS ALSO CLASSIFIED AS A USER ERROR SERIOUS INJURY REPORT AS THE USER WRAPPED THE STYLED AROUND HER HAND AND FORCEFULLY REMOVED; AS PER IFU0101-0, THE USER IS INSTRUCTED TO REMOVE STYLET BY GENTLY PULLING BACK ON THE PLASTIC HUB. THE ECHO-25 DEVICE OF LOT# C997275 HAS NOT BEEN RETURNED FOR EVAL TO DATE. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS THE DEVICE WAS NOT RETURNED FOR EVAL AND CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED IN THE LABORATORY IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND 100% VISUAL INSPECTION TO ENSURE INTEGRITY OF PRODUCT. A REVIEW OF MFG RECORDS FOR LOT# C997275 REVEALED NO ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT REPORT. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE IFU0101-0 INSTRUCTS THE USER PRIOR TO USE TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." THE USER IS ALSO INSTRUCTED IN IFU0101-0 STEP 7 AS FOLLOWS: REMOVE STYLET FROM NEEDLE BY GENTLY PULLING BACK ON PLASTIC HUB SEATED IN METAL FITTING OF NEEDLE HANDLE. PRESERVE STYLET FOR USE IF ADDITIONAL CELL COLLECTION IS DESIRED." AND INSTRUCTED IN STEP 15 AS FOLLOWS: "FOR ADDITIONAL CELL COLLECTION FROM SAME LESION, GENTLY REINSERT STYLET INTO METAL FITTING ON HANDLE. NOTE: PRIOR TO REINSERTING STYLET, WIPE WITH SALINE OR STERILE WATER. WHILE SUPPORTING SHEATH AT LUER LOCK FITTING, ADVANCE STYLET IN SMALL INCREMENTS UNTIL STYLET HUB IS ENGAGED IN FITTING." THE PT DID NOT EXPERIENCE ANY KNOWN ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE NURSE NOTICED LATER AFTER WASHING HER HANDS AND EATING LUNCH THAT HER FINGER WAS BURNING/TINGLING AND NOTICED A PAPER LIKE CUT. SHE WAS SENT TO THE ER AND NEEDLE STICK PROTOCOL WAS ENACTED. ALL TESTS CAME BACK NEGATIVE. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. COMPLAINS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
STYLET APPEARED TO JAM DURING INTRODUCTION OF NEEDLE INTO LESION. THE NURSE ATTEMPTED TO REMOVE THE STYLE AND COULD NOT. DR. TOLD NURSE TO WRAP STYLET AROUND HER HAND AND APPLY FIRM TENSION, WHICH CAUSE THE WIRE TO SNAP AND BREAK APART. NURSE NOTICED LATER AFTER WASHING HANDS AND EATING LUNCH THAT HER FINGER WAS BURNING/TINGLING AND NOTICED A PAPER LIKE CUT. SHE WAS SENT TO THE ER AND NEEDLESTICK PROTOCOL WAS ENACTED. NO ADVERSE EFFECTS TO THE PT WERE REPORTED AS OCCURRING. THE NURSE'S TESTS TAKEN AS PART OF THE NEEDLESTICK PROTOCOL CAME BACK NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577049 | ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE | FCG | COOK IRELAND LTD | C997275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |