ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2023-00493
- Event Type
- Malfunction
- Date Received
- June 22, 2023
- Date of Event
- May 25, 2023
- Report Date
- December 19, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002315201
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
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 C2009435 WAS RETURNED FOR EVALUATION, OPENED WITHOUT ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. CLARIFICATION WAS REQUESTED FROM CUSTOMER AS BELOW: QUESTION: WAS IT THE DISTAL END OF SHEATH THAT WAS OBSERVED TO BE PIERCED THAT THE CUSTOMER MEANT? ANSWER: YES. IT IS THE SHEATH OBSERVED TO BE PIERCED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 29 JUNE 2023. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. REFER THE ATTACHMENTS (B)(4), LAB ATTENDEES AND NOTES ARE IN ¿RETURNED PRODUCT ¿ NOTES¿ SECTION. ON EVALUATION OF THE DEVICE THE BELOW WAS OBSERVED: DISTAL END OF NEEDLE EXAMINED AND NO ISSUES, NEEDLE EXAMINED AND NO ISSUES OBSERVED, DISTAL END OF SHEATH EXAMINED AND OBSERVED TO BE PIERCED, STYLET EXAMINED AND NO ISSUES OBSERVED. SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITH NO ISSUES, NEEDLE UNABLE TO ADVANCE AS IT IS GETTING STUCK AT THE DAMAGE ON THE DISTAL END OF THE SHEATH, STYLET REINSERTED INTO DEVICE AND NO ISSUES OBSERVED, NEEDLE REMOVED FROM THE DEVICE WITHOUT ANY ISSUES. A LAB RE-EVALUATION WAS DONE ON (B)(6) 2023 AND THE BELOW WAS OBSERVED. DISTAL END OF SHEATH EXAMINED, AND OBSERVED TO BE PIERCED APPROX.. 0.1CM FROM TIP OF SHEATH. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-19 OF LOT NUMBER C2009435 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH LOT NUMBER C2009435. INSTRUCTIONS FOR USE AND/LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0101 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: IMAGES RECEIVED UNDERWENT AN IMAGE REVIEW ANALYSIS WHERE THE PENETRATION OF SHEATH BY THE NEEDLE WAS CONFIRMED. IMPRESSION: DESPITE NOT BEING CERTAIN THE IMAGES SUBMITTED FOR REVIEW ACCURATELY PORTRAY THE DESCRIBED EVENT, PENETRATION OF THE BIOPSY DEVICE SHEATH BY THE NEEDLE WOULD LIKELY BE A RESULT OF NOT PROPERLY ALIGNING THE END OF THE NEEDLE WITH THE BIOPSY SHEATH BY USING THE SHEATH ADJUSTER COMPONENT. THIS WOULD HAVE RESULTED IN TOO MUCH OF THE SHEATH EXTENDING OUT OF THE ENDOSCOPE AND LIKELY CREATING AN ANGULATION OR BEND OF THE SHEATH SUCH THAT WHEN THE NEEDLE WAS ADVANCED IT PENETRATED THROUGH THE BEND OF THE SHEATH ITSELF INSTEAD OF TRACKING THROUGH THE SHEATH. THIS WOULD HAVE LIKELY BEEN AVOIDED IF SHEATH ADJUSTER COMPONENT WAS SET UP SUCH THAT THERE WAS NOT A LONG COMPONENT OF THE SHEATH WITHOUT THE NEEDLE INSIDE EXTENDING OUT OF THE ENDOSCOPE. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE ANGLE AT WHICH DEVICE WAS HELD DURING ENDOSCOPY CHANNEL ADVANCEMENT, THIS COULD POTENTIALLY HAVE LED TO THE NEEDLE BECOMING CAUGHT ON THE SHEATH AT SOME POINT DURING THE PROCEDURE, LEADING TO THE SHEATH GETTING PIERCED. ANOTHER POSSIBLE ROOT CAUSE FOR THE SHEATH GETTING PIERCED COULD BE ATTRIBUTED TO THE DIFFICULTIES USER EXPERIENCED TO PENETRATE THE TARGET SITE / DIFFICULTIES GAINING ACCESS TO THE TARGET SITE AS WELL AS THE DIFFICULTIES USER EXPERIENCED WHILE RETRACTING THE NEEDLE. ANOTHER POSSIBLE ROOT CAUSE COULD BE RELATED TO THE THE ADJUSTING OF THE DISTAL SCOPE SO AS TO STRAIN OR FLEX THE NEEDLE WHEN NEEDLE TIP IS ADVANCED INTO THE TARGET SITE, AS PER ENGINEERING INPUT "IF THE USER HAD THE SHEATH EXTENDER EXTENDED ABOVE 3CM AND DEVICE WAS FLEXED AT THE DISTAL POSITION, IT IS LIKELY THAT SHEATH WILL FLEX WITHOUT NEEDLE AND IF THE NEEDLE WAS ADVANCED IT CAN PIERCE THE SHEATH". CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. CORRECTIVE ACTION/ CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, USER DETECTED THE NEEDLE PENETRATED THE SURFACE OF SHEATH DURING BIOPSY IN AMPULLA. CONFIRMED QUANTITY OF 01 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE THAT, A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE ANGLE AT WHICH DEVICE WAS HELD DURING ENDOSCOPY CHANNEL ADVANCEMENT, THIS COULD POTENTIALLY HAVE LED TO THE NEEDLE BECOMING CAUGHT ON THE SHEATH AT SOME POINT DURING THE PROCEDURE, LEADING TO THE SHEATH GETTING PIERCED. ANOTHER POSSIBLE ROOT CAUSE FOR THE SHEATH GETTING PIERCED COULD BE ATTRIBUTED TO THE DIFFICULTIES USER EXPERIENCED TO PENETRATE THE TARGET SITE / DIFFICULTIES GAINING ACCESS TO THE TARGET SITE AS WELL AS THE DIFFICULTIES USER EXPERIENCED WHILE RETRACTING THE NEEDLE. ANOTHER POSSIBLE ROOT CAUSE COULD BE RELATED TO THE ADJUSTING OF THE DISTAL SCOPE SO AS TO STRAIN OR FLEX THE NEEDLE WHEN NEEDLE TIP IS ADVANCED INTO THE TARGET SITE, AS PER ENGINEERING INPUT "IF THE USER HAD THE SHEATH EXTENDER EXTENDED ABOVE 3CM AND DEVICE WAS FLEXED AT THE DISTAL POSITION, IT IS LIKELY THAT SHEATH WILL FLEX WITHOUT NEEDLE AND IF THE NEEDLE WAS ADVANCED IT CAN PIERCE THE SHEATH". COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION.
USER DETECTED THE NEEDLE PENETRATED THE SURFACE OF SHEATH DURING BIOPSY IN AMPULLA. "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."
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE LAB EVALUATION ON 29-JUN-23.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 19-DEC-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1062420 | ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C2009435 | 10827002315201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male |