ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2018-00548
- Event Type
- Injury
- Date Received
- November 27, 2018
- Date of Event
- October 24, 2018
- Report Date
- December 20, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002315204
- PMA / PMN Number
- K083330
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
510 (K) NUMBER; K083330. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510 (K) NUMBER: K083330. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 14 NOV 2018. THE NEEDLE WAS FOUND TO BE BROKEN DISTALLY. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-19 OF LOT NUMBER: C1525135 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER: C1525135. IFU REVIEW: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0101-0, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE" AND "REMOVE STYLET FROM NEEDLE BY GENTLE PULLING BACK ON PLASTIC HUB SEATED IN METAL FITTING OF NEEDLE HANDLE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO USE OF THE STYLET (IFU0101-0). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO USER ERROR AFTER RECEIVING ADDITIONAL INFORMATION ON 27 NOV 2018. THE NEEDLE BROKE AS A RESULT OF OFF LABEL USE FOR PSEUDOCYST DRAINAGE AND USE OF A WIRE GUIDE INSTEAD OF A STYLET. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510 (K) NUMBER; K083330. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER).. EXEMPTION NUMBER: E2016031 INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON , INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
AS REPORTED TO CUSTOMER RELATIONS: "DURING AN ENDOSCOPIC ULTRASOUND. ASPIRATING A PSEUDOCYST THROUGH THE STOMACH WALL. PUNCTURED IN WITH THE NEEDLE AND THEN ASPIRATED AN INJECTED CONTRAST. ATTEMPTED TO PASS GUIDE WIRE THROUGH NEEDLE, AND NEEDLE TIP BROKE OFF INTO STOMACH WALL FROM REST OF CATHETER AND SHEATH AND HAD TO BE REMOVED FROM SCOPE. SUCCESSFULLY REMOVED NEEDLE TIP BROKEN OFF FROM PATIENT AND USED ANOTHER DEVICE TO COMPLETE PROCEDURE. TOOK NEEDLE TIP OUT WITH SNARE. TIP NOT AVAILABLE, REST OF DEVICE IS AVAILABLE FOR RETURN."
AS REPORTED TO CUSTOMER RELATIONS: "DURING AN ENDOSCOPIC ULTRASOUND. ASPIRATING A PSEUDOCYST THROUGH THE STOMACH WALL. PUNCTURED IN WITH THE NEEDLE AND THEN ASPIRATED AN INJECTED CONTRAST. ATTEMPTED TO PASS GUIDE WIRE THROUGH NEEDLE, AND NEEDLE TIP BROKE OFF INTO STOMACH WALL FROM REST OF CATHETER AND SHEATH AND HAD TO BE REMOVED FROM SCOPE. SUCCESSFULLY REMOVED NEEDLE TIP BROKEN OFF FROM PATIENT AND USED ANOTHER DEVICE TO COMPLETE PROCEDURE. TOOK NEEDLE TIP OUT WITH SNARE. TIP NOT AVAILABLE, REST OF DEVICE IS AVAILABLE FOR RETURN." ADDITIONAL INFORMATION PROVIDED BY (B)(6) ON 26NOV2018: "THEY WERE LIKELY USING IT OFF LABEL IF NOT SUPPOSED TO PUT GUIDEWIRE THROUGH IT. MANY HOSPITALS DO THIS FOR PSEUDOCYST DRAINAGE CASES." ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON (B)(6) 2018: "(CAN YOU ADVISE IF THIS DETAIL WAS CORRECT OR IF THE DETAILS WE HAVE ARE INCORRECT?) I DO BELIEVE IT WAS A GUIDE WIRE."
AS REPORTED TO CUSTOMER RELATIONS: "DURING AN ENDOSCOPIC ULTRASOUND. ASPIRATING A PSEUDOCYST THROUGH THE STOMACH WALL. PUNCTURED IN WITH THE NEEDLE AND THEN ASPIRATED AN INJECTED CONTRAST. ATTEMPTED TO PASS GUIDE WIRE THROUGH NEEDLE, AND NEEDLE TIP BROKE OFF INTO STOMACH WALL FROM REST OF CATHETER AND SHEATH AND HAD TO BE REMOVED FROM SCOPE. SUCCESSFULLY REMOVED NEEDLE TIP BROKEN OFF FROM PATIENT AND USED ANOTHER DEVICE TO COMPLETE PROCEDURE. TOOK NEEDLE TIP OUT WITH SNARE. TIP NOT AVAILABLE, REST OF DEVICE IS AVAILABLE FOR RETURN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 945686 | ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G31520 | C1525135 | 00827002315204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |