COLON DECOMPRESSION SET
Report
- Report Number
- 3001845648-2023-00671
- Event Type
- Malfunction
- Date Received
- September 15, 2023
- Report Date
- July 19, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FEG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) #K171619. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #(B)(4). DEVICE EVALUATION 01 X 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, IFU0102, 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). IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO 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. CONFIRMATION OF COMPLAINT COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. FAILURE IDENTIFIED: UNABLE TO REMOVE WIRE GUIDE AND GUIDING CATHETER LEAVING COLON DECOMPRESSION TUBE IN POSITION., 01 DEVICE CONFIRMED USED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO 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. 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. SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATE TO INVESTIGATION. DEVICE EVALUATION: 01 X 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, 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). 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. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. FAILURE IDENTIFIED: UNABLE TO REMOVE WIRE GUIDE AND GUIDING CATHETER LEAVING COLON DECOMPRESSION TUBE IN POSITION., 01 DEVICE CONFIRMED USED. 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.
WHEN USING COLON DECOMPRESSION KIT, THE WIRE AND GREY CATHETER WON¿T COME OUT, EVEN AFTER FLUSHING. THIS IS A REPEATED OCCURRENCE. (NOTE: CSD ALREADY ASKED THE REP DETAILS OF ALL OCCURRENCES THIS DISCREPANCY WAS OBSERVED. FURTHER RECORDS MAY BE INITIATED DEPENDING ON THE REP'S REPLY.) THE HOSPITAL DOES NOT HAVE THE PRODUCTS TO RETURN FOR INVESTIGATION. REP'S REPLY REGARDING PAST OCCURRENCE: , THE CUSTOMER IS UNSURE OF HOW MANY OCCURRENCES THERE HAS BEEN, BUT IT HAS HAPPENED ON MORE THAN ONE OCCASION. I BELIEVE I PUT ANOTHER COMPLAINT THROUGH FOR THIS SAME PRODUCT AT THIS SAME HOSPITAL LAST YEAR. I WAS NOT THERE WHEN THESE OCCURRENCES HAPPENED, AND THEY DID NOT KEEP THE PRODUCTS FOR ME TO RETURN. NO UNINTENDED PART OF THE DEVICE REMAINED 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.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATE TO INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303015 | 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 |