DISPOSABLE ENDOSCOPIC CLEANING BRUSH
Report
- Report Number
- 3001845648-2019-00034
- Event Type
- Malfunction
- Date Received
- January 28, 2019
- Date of Event
- December 28, 2018
- Report Date
- February 25, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- MNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
PMA/510K # CLASS I N/A. 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 CC 28-JAN-2019. INVESTIGATION IS CURRENTLY IN PROGRESS.
PMA/510K # CLASS I N/A. 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). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS CURRENTLY IN PROGRESS.
PMA/510K # CLASS I N/A. 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). (B)(6) 2019. 1. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED THEREFORE A DOCUMENT BASED REVIEW WILL BE PERFORMED. 4. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION RPN # DCB-DV-50 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS 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 DCB-DV-50 OF UNKNOWN LOT NUMBER COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. DISPOSABLE ENDOSCOPIC CLEANING BRUSH SETS DCB-DV-50 OF UNKNOWN LOT NUMBER CONSISTS OF 50 DOUBLE ENDED CLEANING BRUSHES PACKAGED IN PRE-PRINTED PACKAGING. IN THE FINAL QUALITY CONTROL PRODUCE IN STEP 1.1, IT INSTRUCTS THE MANUFACTURING TEAM MEMBER TO CHECK ¿THE CORRECT PART IS IN THE POUCH, CONFORMING TO THE POUCH PRINT. I.E., FOR DCB-DV-50, CHECK THAT THE TUBE HAS A TIPPED BRUSH AT BOTH ENDS AND THAT A VALVE BRUSH ACCOMPANIES IT IN THE POUCH¿ FURTHER IN STEP 1.5, IT INSTRUCTS THE MANUFACTURING TEAM MEMBER IS TO ¿VERIFY THE TUBING IS FREE OF KINKS AND DAMAGE..¿ ALSO IN STEP 1.4 TO ¿VERIFY THE LENGTH. (1/LOT, VISUALLY COMPARE THE REMAINDER).¿ 5. ROOT CAUSE (POSSIBLE): A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE CAUSE OF THIS COMPLAINT COULD BE IF EXCESSIVE PRESSURE WAS APPLIED TO THE CLEANING BRUSH WHEN CLEANING THE SCOPE BUT AS THE DEVICE WAS NOT RETURNED FOR EVALUATION WE CANNOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. DESPITE MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION IT WAS NOT POSSIBLE TO DETERMINE IF ALL THE PARTS THAT BROKE WERE REMOVED FROM THE ENDOSCOPE, ON (B)(6) 2019 THE REP CONFIRMED SHE WAS ¿UNABLE TO GET ANY FURTHER INFORMATION OTHER THAN SUPPLIED AS NO ONE REMEMBER THE EVENT.¿ 6. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.
BRUSHES SNAPPED WHILE BEING GUIDED INTO ENDOSCOPE CHANNEL.
BRUSHES SNAPPED WHILE BEING GUIDED INTO ENDOSCOPE CHANNEL. FDA MDR REPORTING REQUIRED - EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿BRUSH BREAKAGE'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
BRUSHES SNAPPED WHILE BEING GUIDED INTO ENDOSCOPE CHANNEL. FDA MDR REPORTING REQUIRED - EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿BRUSH BREAKAGE'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75643 | DISPOSABLE ENDOSCOPIC CLEANING BRUSH | MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPES | MNL | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |