ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2023-00083
- Event Type
- Malfunction
- Date Received
- February 7, 2023
- Date of Event
- January 9, 2023
- Report Date
- September 8, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002315201
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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: (B)(4) UNIT OF LOT NUMBER C1928781 OF ECHO-19 WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 02 MARCH 2023. VISUAL INSPECTION: - DISTAL END OF NEEDLE EXAMINED AND NO ISSUE OBSERVED. - STYLET EXAMINED AND NO ISSUE OBSERVED. - NEEDLE REMOVED FROM THE DEVICE AND PROXIMAL KINK BELOW THE SHEATH EXTENDER OBSERVED. FUNCTIONAL INSPECTION: - SHEATH EXTENDER ABLE TO RETRACT AND ADVANCE WITH NO ISSUE. - NEEDLE ABLE TO RETRACT WITHOUT ISSUE AND ADVANCE WITH SLIGHT DIFFICULTY. - STYLET REMOVED FROM THE DEVICE WITH NO ISSUE BUT UNABLE TO BE RE-INSERTED PAST THE PROXIMAL KINK BELOW THE SHEATH EXTENDER. MANUFACTURING RECORDS REVIEW: 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 C1928781 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW: 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 C1928781. 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". ALSO, ¿INTENDED USE: THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0101). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. 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 POSSIBILITY THAT THE DEVICE WAS USED IN A TORTUROUS POSITION AS DETAILED BY THE CUSTOMER IN THE ADDITIONAL INFO "9. WAS THE DEVICE USED IN A TORTUOUS POSITION? YES 21. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? YES". THIS LIKELY CAUSED THE PROXIMAL KINK BELOW THE SHEATH EXTENDER WHICH IS HAS CAUSED THE ISSUE WITH RETRACTING THE NEEDLE FULLY. A CAPA HAS BEEN INITIATED TO DOCUMENT AND TRACK THE ACTIONS TAKEN TO INVESTIGATE AND TO ADDRESS KINKING OR BREAKING OF THE SHEATH AT THE SHEATH/SHEATH EXTENDER JUNCTION. SUMMARY: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CORRECTION REPORT TO INCLUDE NEW INFORMATION ON MANUFACTURER AND EXPIRY DATE ON 21-FEB 2023 AND A LAB EVALUATION ON 02-MAR-23.
USER ADJUSTED THE HANDLE TO 0 AFTER FIRST BIOPSY BUT THE NEEDLE TIP STILL CANNOT BE RETRACTED COMPLETELY. THE NEEDLE RETRACTED COMPLETELY AFTERUSER RETRACTED THE NEEDLE FROM ENDOSCOPY. "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 INVESTIGATION ON 08-SEP-23.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107137 | ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1928781 | 10827002315201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male |