ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
Report
- Report Number
- 3001845648-2018-00574
- Event Type
- Malfunction
- Date Received
- December 12, 2018
- Date of Event
- November 14, 2018
- Report Date
- January 9, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002520127
- PMA / PMN Number
- K092359
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
510 (K) NUMBER; K092359. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION. THE MLLA WAS FOUND TO BE OFF CENTRE. THE NEEDLE AND SHEATH WAS ALSO OBSERVED TO BE BROKEN PROXIMAL TO THE SHEATH EXTENDER AND SEPARATED FROM THE HANDLE PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-A 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-HD-19-A OF LOT NUMBER C1436895 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 C1436895. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "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. THE FAILURE OF LEUR LOCK DIFFICULTIES WAS CONCLUDED FROM THE AVAILABLE INFORMATION. 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 EXCESSIVE FORCE CAUSING THE LEUR LOCK TO GO OFF CENTRE AND AS A RESULT THE NEEDLE AND SHEATH BROKE AND SEPARATED FROM THE HANDLE. 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; K092359. 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)(6). 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; K092359. 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.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. AS INITIALLY REPORTED TO CUSTOMER RELATIONS : DURING AN EUS CYSTGASTROESTOMY PROCEDURE THE ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, G52012, WAS USED. THE PHYSICIAN DID NOT REPOSITION STYLET FOR REPUNCTURING. THE SHEATH SNAPPED FROM THE SHEATH. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE; UNKNOWN WHAT MANUFACTURE AND DEVICE. THERE WAS NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: DURING AN EUS CYSTGASTROESTOMY PROCEDURE THE ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, G52012, WAS USED. THE PHYSICIAN DID NOT REPOSITION STYLET FOR REPUNCTURING. THE SHEATH SNAPPED FROM THE SHEATH. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE; UNKNOWN WHAT MANUFACTURE AND DEVICE. THERE WAS NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: DURING AN EUS CYSTGASTROESTOMY PROCEDURE THE ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, G52012, WAS USED. THE PHYSICIAN DID NOT REPOSITION STYLET FOR REPUNCTURING. THE SHEATH SNAPPED FROM THE SHEATH. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE; UNKNOWN WHAT MANUFACTURER AND DEVICE. THERE WAS NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 994115 | ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G52012 | C1436895 | 00827002520127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |