ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2022-00682
- Event Type
- Malfunction
- Date Received
- October 3, 2022
- Date of Event
- July 7, 2022
- Report Date
- April 17, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002315201
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K210476 DEVICE EVALUATION THE ECHO-19 DEVICE OF LOT NUMBER C1821987 WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON (B)(6) 2022. ON EVALUATION OF THE DEVICE THE BELOW WAS OBSERVED: - SHEATH PIERCED APPROX. 0.4CM FROM SHEATH TIP. - DISTAL TIP OF NEEDLE EXAMINED AND FOUND TO BE SLIGHTLY BLUNTED (NOT SHARP). - SLIGHT DISTAL KINK OBSERVED APPROX. 2CM FROM NEEDLE TIP. - SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. - NEEDLE ABLE TO ADVANCE AND RETRACT WITH SOME DIFFICULTY. DOCUMENT REVIEW INCLUDING IFU 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 C1821987 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 C1821987. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER 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". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW N/A ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE ENDOSCOPE BEING IN A FLEXED OR TWISTED POSITION DURING THE PROCEDURE / DIFFICULTIES IN ACCESSING THE TARGET SITE AS DETAILED BY THE CUSTOMER IN THE ADDITIONAL INFORMATION. IT IS POSSIBLE THAT THE NEEDLE PENETRATED THROUGH THE SHEATH AT SOME POINT DUE TO THE ENDOSCOPE BEING IN A FLEXED OR TWISTED POSITION DURING THE PROCEDURE / DIFFICULTIES IN ACCESSING THE TARGET SITE. THE BLUNTING MOST LIKELY OCCURRED DUE TO THE NEEDLE PENETRATING THE SHEATH. 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.
USER ADVANCED THE NEEDLE THROUGH ENDOSCOPY TO DESIRED POSITION, AND DETECTED THE NEEDLE PENETRATED THE SHEATH (0.5CM FROM SHEATH DISTAL END). USER THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END OR PATIENT END)? PATIENT END. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, ETC). PANCREAS. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE.3.0X1.8CM. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED WITH THIS DEVICE? OLYMPUS GF-UCT260 WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? YES. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? YES. WAS NEEDLE PENETRATION OF THE TARGETED SITE DIFFICULT? NO. WAS THE STYLET IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE? YES. HOW MANY BIOPSIES WERE OBTAINED WITH USE OF THIS NEEDLE? 1. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE LAB EVALUATION.
SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 17-APR-2023 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2384151 | ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1821987 | 10827002315201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male |