FUJIFILM EB-530 SERIES BRONCHOSCOPE
Report
- Report Number
- 3001722928-2019-00002
- Event Type
- Malfunction
- Date Received
- March 1, 2019
- Report Date
- April 18, 2019
- Manufacturer
- FUJIFILM CORPORATION
- Product Code
- EOQ
- PMA / PMN Number
- K122535
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
[VIEW OF THE PHYSICIAN WHO TREATED THE PATIENT(S)]: ACCORDING TO THE INCIDENT REPORT SUBMITTED BY THE FACILITY TO THE AUTHORITY, THE INVESTIGATION CONDUCTED BY THE FACILITY DID NOT SHOW ANY POTENTIAL TRANSMISSION IN THE PATIENTS' ENVIRONMENT. IT WAS NOTED THAT WITH THE EXCEPTION OF THE FIRST PATIENT, ALL OTHERS WERE EXAMINED WITH THE SAME BRONCHOSCOPE (SN (B)(4)). IN EARLY (B)(6) 2018 (EXACT DATE NOT SPECIFIED) THE CUSTOMER SENT THE SAMPLES FROM THE BRONCHIAL SECRETIONS OF AFFECTED PATIENTS TO THE NATIONAL REFERENCE CENTER FOR TYPING; THE RESULTS SHOWED THAT THE BACTERIA WAS A CLONE. THE CUSTOMER NOTED THAT THE PSEUDOMONAS AERUGINOSA 3-MRGN (QUINOLONE SENSITIVE) WAS DETECTED IN THE RINSING WATER OF THE INSTRUMENT CHANNEL. THE CUSTOMER SENT THE SECOND SAMPLING TO THE NATIONAL REFERENCE CENTER FOR TYPING; RESULTS WERE NOT PROVIDED TO FUJIFILM. [ASSESSMENT OF THE SUBJECT DEVICE]: THE SUSPECT BRONCHOSCOPES ARE BOTH LOANER DEVICES OWNED BY FEG (FUJIFILM EUROPE GMBH SERVICE CENTER). (B)(4): NOV 15 2018- THE SCOPE WAS RETURNED TO THE FEG SERVICE BRANCH. IT WAS INSPECTED BY FEG AND NO FAILURE WAS FOUND. (B)(4): 22 JAN 2019- THE SCOPE WAS RETURNED TO THE FEG SERVICE BRANCH. IT WAS INSPECTED BY FEG AND FEG FOUND THAT THE DISTAL END CAP WAS DAMAGED. A SERVICE HISTORY REVIEW WAS PERFORMED FOR (B)(4) AND IT WAS FOUND THAT PRIOR TO SENDING THE SCOPE TO THE CUSTOMER FACILITY, THE INSPECTION AT FEG (PERFORMED ON 25 OCT 2018) DID NOT SHOW ANY FAILURES; THEREFORE IT WAS DETERMINED THAT THE FAILURE OCCURRED DURING USE AT THE CUSTOMER FACILITY. [ASSESSMENT OF THE CAUSE OF THE EVENT]: AT THIS TIME FUJIFILM HAS NOT RECEIVED SUFFICIENT INFORMATION TO IDENTIFY THE ROOT CAUSE. IT WAS FOUND THAT THE DISTAL END CAP OF (B)(4) WAS DAMAGED, HOWEVER IT IS UNKNOWN IF THERE IS A CAUSAL RELATIONSHIP BETWEEN THE FAILURE AND THIS INCIDENT, AT THIS TIME. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION: [PATIENT INFORMATION] ALL OF THE AFFECTED PATIENTS RECOVERED AND WERE RELEASED FROM THE HOSPITAL; FUJIFILM WAS NOT ABLE TO OBTAIN ANY OTHER INFORMATION REGARDING THE PATIENTS' STATUSES. [ASSESSMENT OF THE SUBJECT DEVICE] (B)(4): NO ADDITIONAL INFORMATION. (B)(4): INSPECTION FOUND THAT THERE WAS DIRT AROUND THE LG LENS ON THE DISTAL END CAP. ON APRIL 2019, A SAMPLING TEST WAS PERFORMED FOR THE CHANNEL AND DISTAL END OF THE SUBJECT DEVICE. ACINETOBACTER JUNII WAS DETECTED IN THE RINSING WATER OF THE FORCEPS INLET TO DISTAL END SECTION (FORCEPS CHANNEL); THE SCOPE FAILED THE SAMPLING TEST. FOLLOWING THE SAMPLING TEST, REPROCESSING WAS PERFORMED AND THE SAMPLING TEST WAS REPEATED FOR THE FORCEPS CHANNEL AND DISTAL END OF THE DEVICE; SECOND SAMPLING TEST DID NOT DETECT ANY CONTAMINANTS PRESENT. IT IS HYPOTHESIZED THAT THE REASON THAT THE PSEUDOMONAS AERUGINOSA WAS NOT DETECTED DURING THE CULTURE TEST IS BECAUSE THE BACTERIA HAD ALREADY BEEN KILLED DUE TO THE DEVICE BEING STORED IN A DRY STATE FOR AN EXTENDED PERIOD OF TIME. [RESULT OF SITE VISIT] (B)(4): THE FACILITY STAFF DID NOT NOTICE THE DISTAL END CAP DAMAGE AND DIRT ON THE DISTAL END AND CONTINUED TO USE THE DEVICE. ADDITIONALLY, IT WAS OBSERVED THAT THE FACILITY DEVIATED FROM THE RECOMMENDED REPROCESSING PROCEDURE. THE FACILITY DID NOT FOLLOW THE FUJIFILM MANUAL AND USED GAUZE TO CLEAN THE DISTAL END SECTION INSTEAD OF USING A SOFT BRUSH AS INTENDED. [ASSESSMENT OF THE CAUSE OF THE EVENT] THE FIRST EVENT (1 PATIENT, EB-530T(S/N - (B)(4)) THE SUBJECT PATIENT HAD P. AERUGINOSA PRIOR TO UNDERGOING BRONCHOSCOPY; THERE WAS NO DEVICE MALFUNCTION. BASED ON THIS EVIDENCE, IT IS BELIEVED THAT THE INFECTION WAS NOT CAUSED BY THE SUBJECT BRONCHOSCOPE. THE SECOND TO SIXTH EVENT (5 PATIENTS, EB-530T (S/N - (B)(4)) THE FACILITY STAFF DID NOT NOTICE DAMAGE AND DIRT ON THE DISTAL END CAP AND CONTINUED TO USE THE DEVICE. THE FACILITY ALSO DEVIATED FROM THE RECOMMENDED REPROCESSING PROCEDURE CAUSING THE P. AERUGINOSA CONTAMINATION WHICH RESULTED IN INFECTION. THEREFORE, THE ROOT CAUSE IS USER ERROR; FAILURE TO CARRY OUT A PRE-USE INSPECTION AND NOT FOLLOWING THE REPROCESSING PROCEDURE IN THE DEVICE INSTRUCTION MANUAL. THE NECESSARY PRECAUTIONS AND PROCEDURES FOR THE PRE-USE INSPECTION AND REPROCESSING HAVE BEEN DESCRIBED IN THE INSTRUCTION MANUALS OF THE AFFECTED BRONCHOSCOPE. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT A TOTAL OF SIX (6) PATIENTS WERE DETECTED TO HAVE PSEUDOMONAS AERUGINOSA 3-MRGN (QUINOLONE SENSITIVE) IN BRONCHIAL SECRETIONS. ALL PATIENTS HAD BRONCHOSCOPIES COMPLETED WITH EB-530T (ONE PATIENT WITH SN (B)(4) AND FIVE PATIENTS WITH SN (B)(4)). TIMELINE OF THE EVENTS: ON (B)(6) 2018- ONE (1) PATIENT WHO HAD BRONCHOSCOPY USING EB-530T (SN (B)(4)) WAS DETECTED TO HAVE PSEUDOMONAS AERUGINOSA 3-MRGN (QUINOLONE SENSITIVE) IN THE BRONCHIAL SECRETIONS. ON (B)(6) 2018- THIS AGENT COULD ALSO BE DETECTED IN BRONCHIAL SECRETIONS AFTER ENRICHMENT IN FIVE (5) SAMPLES FROM FIVE (5) DIFFERENT PATIENTS. THESE FIVE (5) PATIENTS HAD BRONCHOSCOPY PERFORMED USING EB-530T (SN (B)(4)). THE SUBJECT DEVICE WAS DISCONTINUED. ON (B)(6) 2018- NO FURTHER EVIDENCE OF PSEUDOMONAS AERUGINOSA 3-MRGN OCCURRED. ON (B)(6) 2019- THE EB-530T (SN (B)(4)) WAS SAMPLED AND PSEUDOMONAS AERUGINOSA 3-MRGN WAS DETECTED. ON 31 JAN 2019- THE FACILITY SUBMITTED THE INCIDENT REPORT TO THE AUTHORITY OF THEIR COUNTRY. ON 01 FEB 2019- FEG (FUJIFILM EUROPE GMBH SERVICE CENTER) WAS INFORMED BY THE AUTHORITY REGARDING THIS INCIDENT. AFFECTED DEVICE AND PATIENT INFORMATION: ALL THE AFFECTED PATIENTS HAD BRONCHOSCOPIES PERFORMED IN THE INTENSIVE CARE UNIT (ICU). EXCEPT FOR THE DATE OF BRONCHOSCOPIES WITH THE USED DEVICE, PATIENT INFORMATION IS UNKNOWN. DATE OF BRONCHOSCOPY AND USED DEVICE: ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)). THERE WAS NO DEATH OR SERIOUS INJURY REPORTED; THIS INCIDENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.
[VIEW OF THE PHYSICIAN WHO TREATED THE PATIENT(S)]: ACCORDING TO THE INCIDENT REPORT SUBMITTED BY THE FACILITY TO THE AUTHORITY, THE INVESTIGATION CONDUCTED BY THE FACILITY DID NOT SHOW ANY POTENTIAL TRANSMISSION IN THE PATIENTS' ENVIRONMENT. IT WAS NOTED THAT WITH THE EXCEPTION OF THE FIRST PATIENT, ALL OTHERS WERE EXAMINED WITH THE SAME BRONCHOSCOPE (SN (B)(4)). IN EARLY (B)(6) 2018 (EXACT DATE NOT SPECIFIED) THE CUSTOMER SENT THE SAMPLES FROM THE BRONCHIAL SECRETIONS OF AFFECTED PATIENTS TO THE (B)(6) FOR TYPING; THE RESULTS SHOWED THAT THE BACTERIA WAS A CLONE. THE CUSTOMER NOTED THAT THE PSEUDOMONAS AERUGINOSA 3-MRGN (QUINOLONE SENSITIVE) WAS DETECTED IN THE RINSING WATER OF THE INSTRUMENT CHANNEL. THE CUSTOMER SENT THE SECOND SAMPLING TO THE (B)(6) FOR TYPING; RESULTS WERE NOT PROVIDED TO FUJIFILM. [ASSESSMENT OF THE SUBJECT DEVICE]: THE SUSPECT BRONCHOSCOPES ARE BOTH LOANER DEVICES OWNED BY (B)(4) SERVICE CENTER. (B)(4): (B)(6) 2018 - THE SCOPE WAS RETURNED TO THE (B)(4) SERVICE BRANCH. IT WAS INSPECTED BY (B)(4) AND NO FAILURE WAS FOUND. (B)(4): (B)(6) 2019 - THE SCOPE WAS RETURNED TO THE (B)(4) SERVICE BRANCH. IT WAS INSPECTED BY (B)(4) AND (B)(4) FOUND THAT THE DISTAL END CAP WAS DAMAGED. A SERVICE HISTORY REVIEW WAS PERFORMED FOR (B)(4) AND IT WAS FOUND THAT PRIOR TO SENDING THE SCOPE TO THE CUSTOMER FACILITY, THE INSPECTION AT (B)(4) (PERFORMED ON 25 OCT 2018) DID NOT SHOW ANY FAILURES; THEREFORE IT WAS DETERMINED THAT THE FAILURE OCCURRED DURING USE AT THE CUSTOMER FACILITY. [ASSESSMENT OF THE CAUSE OF THE EVENT]: AT THIS TIME FUJIFILM HAS NOT RECEIVED SUFFICIENT INFORMATION TO IDENTIFY THE ROOT CAUSE. IT WAS FOUND THAT THE DISTAL END CAP OF (B)(4) WAS DAMAGED, HOWEVER IT IS UNKNOWN IF THERE IS A CAUSAL RELATIONSHIP BETWEEN THE FAILURE AND THIS INCIDENT, AT THIS TIME. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT A TOTAL OF SIX (6) PATIENTS WERE DETECTED TO HAVE PSEUDOMONAS AERUGINOSA 3-MRGN (QUINOLONE SENSITIVE) IN BRONCHIAL SECRETIONS. ALL PATIENTS HAD BRONCHOSCOPIES COMPLETED WITH EB-530T (ONE PATIENT WITH SN (B)(4) AND FIVE PATIENTS WITH SN (B)(4)). TIMELINE OF THE EVENTS: ON (B)(6) 2018 - ONE (1) PATIENT WHO HAD BRONCHOSCOPY USING EB-530T (SN - (B)(4)) WAS DETECTED TO HAVE PSEUDOMONAS AERUGINOSA 3-MRGN (QUINOLONE SENSITIVE) IN THE BRONCHIAL SECRETIONS. ON (B)(6) 2018 - THIS AGENT COULD ALSO BE DETECTED IN BRONCHIAL SECRETIONS AFTER ENRICHMENT IN FIVE (5) SAMPLES FROM FIVE (5) DIFFERENT PATIENTS. THESE FIVE (5) PATIENTS HAD BRONCHOSCOPY PERFORMED USING EB-530T (SN- (B)(4)). THE SUBJECT DEVICE WAS DISCONTINUED. ON (B)(6) 2018 - NO FURTHER EVIDENCE OF PSEUDOMONAS AERUGINOSA 3-MRGN OCCURRED. ON (B)(6) 2019 - THE EB-530T (SN - (B)(4)) WAS SAMPLED AND PSEUDOMONAS AERUGINOSA 3-MRGN WAS DETECTED. ON (B)(6) 2019 - THE FACILITY SUBMITTED THE INCIDENT REPORT TO THE AUTHORITY OF THEIR COUNTRY. ON (B)(6) 2019 - (B)(4) SERVICE CENTER WAS INFORMED BY THE AUTHORITY REGARDING THIS INCIDENT. AFFECTED DEVICE AND PATIENT INFORMATION: ALL THE AFFECTED PATIENTS HAD BRONCHOSCOPIES PERFORMED IN THE INTENSIVE CARE UNIT (ICU). EXCEPT FOR THE DATE OF BRONCHOSCOPIES WITH THE USED DEVICE, PATIENT INFORMATION IS UNKNOWN. DATE OF BRONCHOSCOPY AND USED DEVICE: ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)), ON (B)(6) 2018 EB-530T (SN - (B)(4)). THERE WAS NO DEATH OR SERIOUS INJURY REPORTED; THIS INCIDENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177358 | FUJIFILM EB-530 SERIES BRONCHOSCOPE | VIDEO BRONCHOSCOPE (FLEXIBLE OR RIGID) | EOQ | FUJIFILM CORPORATION | EB-530T | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |