ZIMMON PANCREATIC STENT
Report
- Report Number
- 3001845648-2018-00387
- Event Type
- Malfunction
- Date Received
- August 16, 2018
- Date of Event
- July 13, 2018
- Report Date
- October 11, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 00827002229808
- PMA / PMN Number
- K900923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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.
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). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). AS THE SPSOF-5-5 PRODUCT OF LOT: C1356249 WAS RETURNED A PHYSICAL EVALUATION AND DOCUMENTATION BASED INVESTIGATION WAS COMPLETED. THE SPSOF-5-5 PRODUCT OF LOT: C1356249 WHICH IS INVOLVED IN THIS COMPLAINT WAS RETURNED TO CIRL FOR A LAB EVALUATION. A LAB EVALUATION WAS HELD ON 6TH SEP 2018. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY WHERE THE STENT WAS FOUND TO BE SPLIT FROM THE FLAP TO THE TIP OF THE STENT, THERE WAS ALSO A MINOR INDENTATION NOTED ON THE TIP OF THE STENT ON THE PIGTAIL END. ROOT CAUSE: IT SHOULD BE NOTED THAT THE CUSTOMER STATED THAT THIS FAILURE WAS IDENTIFIED PRIOR TO USE DURING INSPECTION, IT IS POSSIBLE THAT THE DEVICE BECAME DAMAGED DURING TRANSPORTATION OR STORAGE IT IS ALSO POSSIBLE THAT THE DAMAGE WAS SUSTAINED DURING THE PREPARATION STAGE AFTER OPENING THE DEVICE, THE DAMAGE IS CONSISTENT WITH THE FLAP BECOMING CAUGHT ON A SHARP OBJECT OR WIREGUIDE DURING PREPARATION, HOWEVER AS THE EXACT OPERATIONAL CONDITIONS OF USE ARE UNKNOWN THIS CANNOT BE CONCLUSIVELY DETERMINED, DUE TO VARIOUS INSPECTIONS OF THE PRODUCT AT QUALITY CONTROL AND FINAL QUALITY CONTROL IT IS NOT LIKELY THAT THE DEVICE LEFT COOK IRELAND DAMAGED. DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZIMMON PANCREATIC STENT DEVICE OF LOT: C1356249 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT#: C1356249; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT#: C1356249. PRIOR TO DISTRIBUTION, ALL SPSOF-5-5 DEVICES ARE SUBJECTED TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0055-3, THE USER IS INSTRUCTED TO: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RISK WAS DETERMINED TO BE NO RISK (CATEGORY III). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
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) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE". USER CHECKED THE INTEGRITY OF THE DEVICE BEFORE USE AND FOUND OUT THERE IS AN OBVIOUS BREACH AT THE DISTAL END OF THE DEVICE. USER DIDN'T USE THE DEVICE AND CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE." USER CHECKED THE INTEGRITY OF THE DEVICE BEFORE USE AND FOUND OUT THERE IS AN OBVIOUSE BREACH AT THE DISTAL END OF THE DEIVCE. USER DIDN'T USE THE DEVICE AND CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE". USER CHECKED THE INTEGRITY OF THE DEVICE BEFORE USE AND FOUND OUT THERE IS AN OBVIOUSE BREACH AT THE DISTAL END OF THE DEIVCE. USER DIDN'T USE THE DEVICE AND CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE" USER CHECKED THE INTEGRITY OF THE DEVICE BEFORE USE AND FOUND OUT THERE IS AN OBVIOUS BREACH AT THE DISTAL END OF THE DEVICE. USER DIDN'T USE THE DEVICE AND CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632657 | ZIMMON PANCREATIC STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | G22980 | C1356249 | 00827002229808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |