COLON DECOMPRESSION SET
Report
- Report Number
- 3001845648-2022-00791
- Event Type
- Malfunction
- Date Received
- November 22, 2022
- Date of Event
- October 26, 2022
- Report Date
- July 19, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FEG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA/510(K) #: K171619. DEVICE EVALUATION THE CDSG-14-175 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL CDSG-14-175 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. REVIEW OF HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿VISUALLY INSPECT THE PACKAGING AND DEVICE. IF THE PACKAGING IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. IF A DEVICE ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO INCLUDE THE POSITION OF THE COLONOSCOPE DURING DEVICE PLACEMENT. IT¿S POSSIBLE THAT THE IF THE COLONOSCOPE WAS IN A FLEXED POSITION DURING PLACEMENT OF THE DEVICE IT MAY HAVE CAUSED OR CONTRIBUTED TO DIFFICULTY WHEN REMOVING THE WIRE GUIDE/GUIDING CATHETER TO LEAVE THE DECOMPRESSION TUBE IN PLACE. IT¿S ALSO POSSIBLE THAT A DIFFICULT/TORTUOUS PATIENT ANATOMY MAY HAVE EXERTED EXTRINSIC FORCE ON THE DEVICE DURING PLACEMENT AND/OR REMOVAL OF THE WIRE GUIDE/GUIDING CATHETER. THIS FORCE MAY HAVE CAUSED AND/OR CONTRIBUTED TO COMPRESSION OF THE DEVICE RESULTING IN THE DECOMPRESSION TUBE BECOMING STUCK ON THE WIRE GUIDE AND/OR THE USER EXPERIENCING DIFFICULTY IN REMOVING THE WIRE GUIDE AND GUIDING CATHETER. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. A POSSIBLE ROOT CAUSE IS ATTRIBUTED TO DIFFICULT PATIENT ANATOMY. 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.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATES TO INVESTIGATION FINDINGS TO BE REPORTED. DEVICE EVALUATION THE CDSG-14-175 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL CDSG-14-175 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES. REVIEW OF HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE, IFU0102-4, STATES THE FOLLOWING: ¿VISUALLY INSPECT THE PACKAGING AND DEVICE. IF THE PACKAGING IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. IF A DEVICE ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU (IFU0102-4). IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF THE DIFFICULTY IN REMOVING THE INNER CATHETER CAN BE ATTRIBUTED TO THE PATIENT EXHIBITING A DIFFICULT /TORTUOUS ANATOMY WHICH MAY HAVE REQUIRED THE USER TO ALTER THE POSITION AND ADOPT A MORE FLEXED/ANGULATED POSITION WHEN ADVANCING THE GUIDING CATHETER AND THE DECOMPRESSION TUBE WHICH LED TO THE SUBSEQUENT DIFFICULTY IN REMOVING THE CATHETER. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF THE DIFFICULTY IN REMOVING THE INNER CATHETER CAN BE ATTRIBUTED TO THE PATIENT EXHIBITING A DIFFICULT /TORTUOUS ANATOMY WHICH MAY HAVE REQUIRED THE USER TO ALTER THE POSITION AND ADOPT A MORE FLEXED/ANGULATED POSITION WHEN ADVANCING THE GUIDING CATHETER AND THE DECOMPRESSION TUBE WHICH LED TO THE SUBSEQUENT DIFFICULTY IN REMOVING THE CATHETER. 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.
PMA/510(K) # K171619. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-JAN-23.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATES TO INVESTIGATION FINDINGS TO BE REPORTED.
NURSES COMPLAINED THAT IT HAS BEEN DIFFICULT TO REMOVE THE WIRE FROM THE COLON DECOMPRESSION TUBE FOLLOWING PLACEMENT IN A PATIENT. THEY SAID THIS HAS HAPPENED WITH THIS PRODUCT MANY TIMES. THE REP ADVISED THAT THEY HAVE NOT BEEN REPORTED BEFORE AS IT WAS REPORTED TO HER FOR THE FIRST TIME YESTERDAY ((B)(4)) AND THE CUSTOMER SAID THAT IT HAPPENS ALL THE TIME WITH THIS PRODUCT. SHE ASKED THE CUSTOMER HOW MANY TIMES IT HAS HAPPENED AND THEY SAID IT HAPPENS MOST TIMES THEY USED IT BUT COULDN¿T GIVE ME AN EXACT NUMBER. NOTE: CSD REQUESTED INFORMATION ON HOW MANY TIMES IT OCCURRED (INCLUDING THE DATES), IF THEY HAVE BEEN REPORTED TO CSD IN THE PAST, THE LOT NUMBERS INVOLVED AND THE PATIENT OUTCOME FOR EACH OF THE OCCURRENCE. REPLY FROM THE REP WAS RECEIVED ON 28/10/22: THEY SAID THAT IT HAPPENS 5 TIMES PER YEAR ((B)(4)), BUT THEY DO NOT HAVE THE DATES OF OCCURRENCES, THE LOT NUMBERS INVOLVED OR THE PATIENT OUTCOME FOR THESE PAST OCCURRENCES. ONLY THE COMPRESSION TUBE REMAINS INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE. 1. WAS THE DEVICE FLUSHED BEFORE USE? YES 2. WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, ETC.)? WATER 4. WAS LUBRICATION APPLIED TO THE DECOMPRESSION TUBE? YES 5. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? JAGWIRE 6. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? N/A 7. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. COLON 8. HOW EXPERIENCED WAS THE PHYSICIAN WITH USING THE CDSG? UNKNOWN 9. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO 10. WHAT INTERVENTION (IF ANY) WAS REQUIRED? N/A 11. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A 12. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO 13. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. N/A 14. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS, MODEL NUMBER UNKNOWN 15. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DECOMPRESSION TUBE INTO POSITION? NO 16. IF RESISTANCE WAS ENCOUNTERED, WAS THE ENDOSCOPE WITHDRAWN A SHORT DISTANCE? N/A 17. HOW OFTEN WAS THE DECOMPRESSION TUBE IRRIGATED? UNKNOWN 18. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO 19. HOW LONG WAS THE SET LEFT IN DWELLING? UNKNOWN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1725607 | COLON DECOMPRESSION SET | FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION | FEG | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |