FUJIFILM DUODENOSCOPE
Report
- Report Number
- 3001722928-2020-00016
- Event Type
- Death
- Date Received
- October 16, 2020
- Report Date
- November 9, 2020
- Manufacturer
- FUJIFILM CORPORATION
- Product Code
- FDT
- PMA / PMN Number
- K191747
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
UPDATED INFORMATION IS BEING PROVIDED IN SECTION B5 (PATIENT INFORMATION, STATUS OF PATIENT #2, TYPE OF PROCEDURE AND INDICATIONS FOR PROCEDURE), B7, H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H10 (NARRATIVE). ADDITIONAL INFORMATION FROM THE HOSPITAL AND DISTRIBUTOR OBTAINED ON OCTOBER 20, 2020 LED TO THE CONCLUSION THAT THE HOSPITAL HAS NOT BEEN FOLLOWING THE REPROCESSING INSTRUCTIONS AS DESCRIBED IN THE CLEANING MANUAL. FUJIFILM FOUND THAT THE HOSPITAL NEVER PURCHASED THE FUJIFILM SPECIAL ACCESSORIES INTENDED FOR THE SUBJECT SCOPE AND THAT THE PATIENT SINGLE USE ACCESSORIES WERE REUSED. A FEW OF THE ACCESSORIES ARE UNIQUE AND SPECIALLY DESIGNED FOR THE DUODENOSCOPE ED-530XT8 AND ONLY AVAILABLE FROM FUJIFILM OR THEIR DISTRIBUTORS AND NOT AVAILABLE ON THE THIRD PARTY MARKET. FUJIFILM CONCLUSION: A COMBINATION OF NOT FOLLOWING THE INTENDED REPROCESSING METHOD, REUSE OF PATIENT SINGLE USE ACCESSORIES AND NOT MAINTAINING THE ENDOSCOPE ACCORDING TO THE INSTRUCTIONS HAS A HIGH POTENTIAL RISK OF CONTAMINATION SUCH AS TRANSFER OF PSEUDOMONAS FROM PATIENT TO PATIENT. THE HOSPITAL HAS BEEN SWAB TESTING ALL THREE ED-530XT8 DUODENOSCOPES ON A ROUTINE BASIS SINCE THIS ISSUE OCCURRED AND CONFIRMED THAT TO DATE NO PSEUDOMONAS HAVE BEEN DETECTED. THE HOSPITAL WANTS TO HAVE ADDITIONAL REPROCESSING TRAINING. FUJIFILM AND ITS DISTRIBUTOR WILL CONTACT HOSPITAL TO SCHEDULE THE ADDITIONAL TRAINING. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ON SEPTEMBER 22, 2020 FUJIFILM CORPORATION WAS INFORMED THAT A PATIENT AT A MEDICAL FACILITY IN THE UNITED KINGDOM (UK) DIED AFTER A PROCEDURE WITH A FUJIFILM SCOPE. ADDITIONAL FOLLOW UP REVEALED THAT A SECOND PATIENT DIED AS WELL. THE PATIENTS UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR JAUNDICE. THE PATIENTS HAD PANCREATIC CANCER AND RECEIVED INTRAVENOUS ANTIBIOTICS ONCE THEY TESTED POSITIVE FOR INFECTION; THE COMMON LINK WAS DETERMINED TO BE A FUJIFILM SCOPE. THE HOSPITAL SUSPENDED ALL THREE FUJIFILM ED-530XT8 DUODENOSCOPES FOR FURTHER INVESTIGATION AND REMOVED FROM SERVICE AND SWABBED. PSEUDOMONAS WAS FOUND TO BE PRESENT ON THE DISTAL END OF THE SUBJECT SCOPE. TIMELINE: PATIENT 1 - (B)(6)2019 - ERCP PROCEDURE FOR JAUNDICE. (B)(6)2019 - SIGNS OF SEPSIS NOTED, PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS. (B)(6)2019 - PATIENT HAD MULTI-ORGAN FAILURE AND DIED. PATIENT 2 - (B)(6)2020 - ERCP PROCEDURE FOR OBSTRUCTIVE JAUNDICE. (B)(6)2020 - PSEUDOMONAS INFECTION DETECTED, PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS. (B)(6)2020 - PATIENT DIED. (B)(6)2020 (SPECIFIC DAY UNKNOWN) - THE FACILITY REQUESTED INSPECTION OF THE SUBJECT SCOPE (AT THAT TIME, INFORMATION ON PATIENT HEALTH HAZARDS WAS NOT PROVIDED TO LOCAL SERVICE). (B)(6)2020 - THE SUBJECT SCOPE WAS RECEIVED AT THE DISTRIBUTOR SERVICE FACILITY IN VERY POOR CONDITION. (B)(6)2020 - THE SUBJECT SCOPE WAS REPAIRED AND RETURNED TO THE FACILITY. THE REPAIRED SCOPE TESTED NEGATIVE. (B)(6)2020 (SPECIFIC DAY UNKNOWN) - THE INCIDENT REPORT WAS SUBMITTED TO THE MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) BY THE CUSTOMER. (B)(6)2020 - THE MHRA CONTACTED THE FUJIFILM LOCAL SUBSIDIARY FUJIFILM EUROPE GMBH, AND ON THE SAME DAY THE LOCAL SUBSIDIARY CONTACTED FUJIFILM CORPORATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
INITIAL REPORTER WAS THE (B)(6). 510(K) USED IS FOR US MARKETED SIMILAR DEVICE ED-580XT. THE FUJIFILM LOCAL SERVICE WAS REQUESTED TO REPAIR THE SUBJECT SCOPE. THE INSPECTION REVEALED A SUBSTANTIAL AMOUNT OF DAMAGE. FUJIFILM SERVICE CARRIED OUT AN OVERHAUL REPAIR INCLUDING REPLACEMENT OF THE INTERNAL MECHANISM. AFTER THE REPAIR WAS COMPLETED, THE SCOPE WAS RETURNED TO THE CUSTOMER AND WAS CONTINUED TO BE USED AT THE FACILITY. AT THIS TIME, DETAILS SUCH AS THE PATIENT'S HEALTH HAZARD, THE CAUSAL RELATIONSHIP BETWEEN THE CAUSE OF DEATH AND THE DEVICE, AND THE REPROCESS PROCESS AT THE FACILITY HAVE NOT BEEN CLARIFIED. THE INVESTIGATION IS ONGOING. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ON SEPTEMBER 22, 2020 FUJIFILM CORPORATION WAS INFORMED THAT A PATIENT AT A MEDICAL FACILITY IN THE (B)(6) DIED AFTER A PROCEDURE WITH A FUJIFILM SCOPE. THE DECEASED PATIENT TESTED POSITIVE FOR PSEUDOMONAS, THE SAME STRAIN WAS ALSO FOUND IN A SECOND PATIENT; THE COMMON LINK WAS DETERMINED TO BE A FUJIFILM SCOPE. THE SCOPE WAS REMOVED FROM SERVICE AND SWABBED. PSEUDOMONAS WAS FOUND TO BE PRESENT ON THE DISTAL END OF THE SCOPE. TIMELINE: (DATE UNKNOWN) INFECTION OCCURRED IN PATIENTS (2 PATIENTS). (DATE UNKNOWN) ONE PATIENT DIED. OUTCOME OF SECOND PATIENT IS UNKNOWN. (DATE UNKNOWN) THE SUBJECT SCOPE TESTED POSITIVE AT THE CUSTOMER FACILITY. ON MARCH 2020 (SPECIFIC DAY UNKNOWN) THE FACILITY REQUESTED INSPECTION OF THE SUBJECT SCOPE (AT THAT TIME, INFORMATION ON PATIENT HEALTH HAZARDS WAS NOT PROVIDED TO LOCAL SERVICE). (DATE UNKNOWN) THE SUBJECT SCOPE WAS RETURNED TO THE FACILITY. THE REPAIRED SCOPE TESTED NEGATIVE. ON SEPTEMBER 2020 (SPECIFIC DAY UNKNOWN) THE INCIDENT REPORT WAS SUBMITTED TO THE (B)(6) BY THE CUSTOMER. ON SEPTEMBER 22, 2020 THE (B)(6) CONTACTED THE FUJIFILM LOCAL SUBSIDIARY FUJIFILM EUROPE (B)(6), AND ON THE SAME DAY THE LOCAL SUBSIDIARY CONTACTED FUJIFILM CORPORATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1155326 | FUJIFILM DUODENOSCOPE | ENDOSCOPE | FDT | FUJIFILM CORPORATION | ED-530XT8 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |