ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2023-00078
- Event Type
- Malfunction
- Date Received
- February 5, 2023
- Date of Event
- January 10, 2023
- Report Date
- August 4, 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 C1881377 WAS RETURNED FOR EVALUATION, OPENED WITH ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. CLARIFICATION WAS REQUESTED FROM CUSTOMER AS BELOW: QUESTION: WOULD YOU CLARIFY IF THE DAMAGE WAS NOTICED BEFORE THE DEVICE WAS USED (THAT IS FROM REMOVING DEVICE FROM PACKAGE) OR DAMAGE WAS NOTICED BEFORE PATIENT CONTACT? ANSWER: IT IS DETECTED BEFORE PATIENT CONTACT. CUSTOMER CONFIRMED THE DEVICE ISSUE OCCURRED DURING ENDOSCOPY CHANNEL ADVANCEMENT WHILE THE DEVICE HAS NO CONTACT WITH PATIENT YET. CUSTOMER ALSO RESPONDED THAT IT IS UNKNOWN IF THE TIP WAS IN ENDOSCOPY OR NOT BUT THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 2 MARCH 2023. ON EVALUATION OF THE DEVICE THE BELOW WAS OBSERVED: DISTAL END OF NEEDLE EXAMINED AND DISTAL BREAK OBSERVED APPROXIMATELY 8 CM FROM TIP OF SHEATH. DISTAL END OF SHEATH EXAMINED AND OBSERVED TO BE SLIGHTLY FRAYED. SHEATH EXTENDER ABLE TO RETRACT AND ADVANCE WITH NO ISSUE. NEEDLE ABLE TO ADVANCE AND RETRACT WITH NO ISSUE. 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 C1881377 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 C1881377. 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: AN IMAGE WAS NOT RETURNED FOR EVALUATION. 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 NEEDLE BREAKING DUE TO DEVICE HANDLING / THE ANGLE AT WHICH DEVICE WAS HELD DURING ENDOSCOPY CHANNEL ADVANCEMENT. DEVICE DAMAGE COULD ALSO HAVE OCCURRED ON INSERTION INTO THE SCOPE RESULTING IN THE DISTAL NEEDLE BREAK. IT IS POSSIBLE THAT THE SHEATH GOT CAUGHT ON THE NEEDLE OR WAS IMPACTED WHEN THE NEEDLE BROKE WHICH RESULTED IN THE SHEATH DAMAGE AND SHEATH FRAYING OBSERVED IN THE LAB EVALUATION. 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, THE DISTAL END OF SHEATH BROKE DURING ENDOSCOPY CHANNEL ADVANCEMENT. CONFIRMED QUANTITY OF (B)(4) DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE THAT, IT IS POSSIBLE THAT THE SHEATH GOT CAUGHT ON THE NEEDLE OR WAS IMPACTED WHEN THE NEEDLE BROKE WHICH RESULTED IN THE SHEATH DAMAGE AND SHEATH FRAYING OBSERVED. COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION.
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
USER DETECTED THE NEEDLE DEVICE ABNORMAL BEFORE USE(NO PATIENT CONTACT), AND FOUND OUT THE DISTAL END OF SHEATH BROKEN DURING BIOPSY. USER RETRACTED THE DEVICE FROM ENDOSCOPY AND THE SHEATH DETACHED. "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."
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE ADDITION OF LAB RE-EVALUATION ON 05-JUL-23.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 04-AUG-2023.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE ADDITION OF LAB EVALUATION NOTES ON 02MAR2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64702 | ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1881377 | 10827002315201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |