VIDEO DUODENOSCOPE
Report
- Report Number
- 7548459
- Event Type
- Injury
- Date Received
- May 29, 2018
- Date of Event
- May 22, 2018
- Report Date
- May 23, 2018
- Manufacturer
- PENTAX OF AMERICA, INC.
- Product Code
- FDT
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
IN EARLY APRIL OF 2018, THE PATIENT (REFERRED TO AS PATIENT B) UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) FOR PRIMARY SCLEROSING CHOLANGITIS WITH PENTAX DUODENOSCOPE. TWO DAYS AFTER INITIAL ERCP, THE PATIENT PRESENTED FROM HOME TO THE EMERGENCY ROOM WITH RIGHT UPPER QUADRANT (RUQ) PAIN, BODY ACHES, SHAKING CHILLS AND FEVERS TO 101.8. SIX DAYS POST INITIAL ERCP, THE PATIENT UNDERWENT ANOTHER ERCP; A BILE DUCT ASPIRATE GREW OUT MULTI-DRUG RESISTANT (MDR) PSEUDOMONAS AERUGINOSA (PSA). THE PATIENT HAD NO PRIOR HISTORY OF THIS ORGANISM. INFECTION CONTROL WAS ALERTED TO PATIENT B BY THE INFECTIOUS DISEASE (ID) CONSULT PHYSICIAN SEEING THE PATIENT FOURTEEN DAYS POST INITIAL ERCP. INFECTION CONTROL UNIT INVESTIGATION IDENTIFIED A PATIENT WHO HAD UNDERGONE AN ERCP IN EARLY JANUARY OF 2018 WITH THE SAME PENTAX DUODENOSCOPE WHO WAS KNOWN TO CARRY A MDR PSA PRIOR TO THE PROCEDURE. THIS PATIENT (REFERRED TO AS PATIENT A) HAD MDR PSA WITH IDENTICAL ANTIBIOTIC RESISTANCE PATTERN AS PATIENT B. GIVEN THE ISOLATION OF AN MDR PSA IN TWO PATIENTS WITH AN EPIDEMIOLOGICALLY LINKED DUODENOSCOPE, THE PENTAX DUODENOSCOPE WAS SEQUESTERED AND TAKEN OUT OF SERVICE PENDING FURTHER INVESTIGATION NEAR THE END OF APRIL 2018. REVIEW OF PATIENT RECORDS WHO HAD BEEN EXPOSED TO DUODENOSCOPE WAS BEGUN, AND AT THE END OF APRIL 2018, AN ADDITIONAL PATIENT (PATIENT C) WITH AN ERCP PERFORMED IN MID-APRIL 2018 WITH PENTAX DUODENOSCOPE, DEVELOPED BACTEREMIA WITH MDR PSA. THIS PSA HAD A SLIGHTLY DIFFERENT ANTIBIOGRAM THAN PATIENT A AND PATIENT B, BUT WITH MANY SIMILARITIES, AND WAS CONSIDERED AS POTENTIALLY RELATED TO PATIENT A. PATIENT C HAD NO KNOWN HISTORY OF MDR PSA. TO DETERMINE IF THE INFECTIONS WERE SIMILAR, THE PSEUDOMONAS ISOLATES WERE SENT OUT FOR GENOMIC ANALYSIS INCLUDING MULTILOCUS SEQUENCE TYPING(MLST) AND WHOLE GENOME SEQUENCING(WGS) IN MID-MAY 2018. SEVEN DAYS POST TESTING BEING SENT OUT, PRELIMINARY RESULTS DEMONSTRATED THE ISOLATES FROM PATIENTS B AND C WERE HIGHLY RELATED TO PATIENT A. NEAR THE END OF MAY 2018, THE FINAL RESULTS WERE PROVIDED CONFIRMING THIS FINDING, WITH BETWEEN 1-3 SINGLE NUCLEOTIDE POLYMORPHISMS(SNP) DIFFERENCES BETWEEN PATIENT A TO PATIENT B AND C. INFECTION CONTROL CONTINUES TO INVESTIGATE ANY ADDITIONAL POTENTIAL INFECTIONS IN PATIENTS EXPOSED TO THIS SCOPE. IN MID-MAY 2018, AN ADDITIONAL PATIENT (PATIENT D*) WHO UNDERWENT ERCP WITH THE SAME SCOPE IN MID-APRIL 2018 WAS FOUND TO HAVE A POSITIVE BILE CULTURE FOR PSA IN EARLY MAY 2018 (NOT INCLUDED ON ORIGINAL SURVEILLANCE REPORT PERFORMED IN EARLY MAY 2018 AS IT WAS NOT SPECIATED OR SUSCEPTIBILITIES DONE UNTIL AFTER EARLY MAY 2018,). BOTH MDR PSAS FROM PATIENT D HAVE THE SAME ANTIBIOGRAM AS PATIENT A; GENOMIC ANALYSIS TO CONFIRM RELATEDNESS IS PENDING AT THIS TIME. MANUFACTURER RESPONSE FOR DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID, VIDEO DUODENOSCOPE (PER SITE REPORTER). PENTAX MEDICAL HAS BEEN MADE AWARE AND IS VERY INTERESTED IN WORKING WITH US ON THIS INVESTIGATION.
IN EARLY (B)(6) 2018, THE PATIENT (REFERRED TO AS PATIENT B) UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) FOR PRIMARY SCLEROSING CHOLANGITIS WITH PENTAX DUODENOSCOPE. TWO DAYS AFTER INITIAL ERCP, THE PATIENT PRESENTED FROM HOME TO THE EMERGENCY ROOM WITH RIGHT UPPER QUADRANT (RUQ) PAIN, BODY ACHES, SHAKING CHILLS AND FEVERS TO 101.8. SIX DAYS POST INITIAL ERCP, THE PATIENT UNDERWENT ANOTHER ERCP; A BILE DUCT ASPIRATE GREW OUT MULTI-DRUG RESISTANT (MDR) PSEUDOMONAS AERUGINOSA (PSA). THE PATIENT HAD NO PRIOR HISTORY OF THIS ORGANISM. INFECTION CONTROL WAS ALERTED TO PATIENT B BY THE INFECTIOUS DISEASE (ID) CONSULT PHYSICIAN SEEING THE PATIENT FOURTEEN DAYS POST INITIAL ERCP. INFECTION CONTROL UNIT INVESTIGATION IDENTIFIED A PATIENT WHO HAD UNDERGONE AN ERCP IN EARLY (B)(6) 2018 WITH THE SAME PENTAX DUODENOSCOPE WHO WAS KNOWN TO CARRY A MDR PSA PRIOR TO THE PROCEDURE. THIS PATIENT (REFERRED TO AS PATIENT A) HAD MDR PSA WITH IDENTICAL ANTIBIOTIC RESISTANCE PATTERN AS PATIENT B. GIVEN THE ISOLATION OF AN MDR PSA IN TWO PATIENTS WITH AN EPIDEMIOLOGICALLY LINKED DUODENOSCOPE, THE PENTAX DUODENOSCOPE WAS SEQUESTERED AND TAKEN OUT OF SERVICE PENDING FURTHER INVESTIGATION NEAR THE END OF (B)(6) 2018. REVIEW OF PATIENT RECORDS WHO HAD BEEN EXPOSED TO DUODENOSCOPE WAS BEGUN, AND AT THE END OF (B)(6) 2018, AN ADDITIONAL PATIENT (PATIENT C) WITH AN ERCP PERFORMED IN MID - (B)(6) 2018 WITH PENTAX DUODENOSCOPE, DEVELOPED BACTEREMIA WITH MDR PSA. THIS PSA HAD A SLIGHTLY DIFFERENT ANTIBIOGRAM THAN PATIENT A AND PATIENT B, BUT WITH MANY SIMILARITIES, AND WAS CONSIDERED AS POTENTIALLY RELATED TO PATIENT A. PATIENT C HAD NO KNOWN HISTORY OF MDR PSA. TO DETERMINE IF THE INFECTIONS WERE SIMILAR, THE PSEUDOMONAS ISOLATES WERE SENT OUT FOR GENOMIC ANALYSIS INCLUDING MULTILOCUS SEQUENCE TYPING(MLST) AND WHOLE GENOME SEQUENCING(WGS) IN MID - (B)(6) 2018. SEVEN DAYS POST TESTING BEING SENT OUT, PRELIMINARY RESULTS DEMONSTRATED THE ISOLATES FROM PATIENTS B AND C WERE HIGHLY RELATED TO PATIENT A. NEAR THE END OF (B)(6) 2018, THE FINAL RESULTS WERE PROVIDED CONFIRMING THIS FINDING, WITH BETWEEN 1-3 SNP DIFFERENCES BETWEEN PATIENT A TO PATIENT B AND C. INFECTION CONTROL CONTINUES TO INVESTIGATE ANY ADDITIONAL POTENTIAL INFECTIONS IN PATIENTS EXPOSED TO THIS SCOPE. IN MID - (B)(6) 2018, AN ADDITIONAL PATIENT (PATIENT D*) WHO UNDERWENT ERCP WITH THE SAME SCOPE IN MID - (B)(6) 2018 WAS FOUND TO HAVE A POSITIVE BILE CULTURE FOR PSA IN EARLY (B)(6) 2018 (NOT INCLUDED ON ORIGINAL SURVEILLANCE REPORT PERFORMED IN EARLY (B)(6) 2018 AS IT WAS NOT SPECIATED OR SUSCEPTIBILITIES DONE UNTIL AFTER EARLY (B)(6) 2018,). BOTH MDR PSAS FROM PATIENT D HAVE THE SAME ANTIBIOGRAM AS PATIENT A; GENOMIC ANALYSIS TO CONFIRM RELATEDNESS IS PENDING AT THIS TIME. MANUFACTURER RESPONSE FOR DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID, VIDEO DUODENOSCOPE (PER SITE REPORTER): PENTAX MEDICAL HAS BEEN MADE AWARE AND IS VERY INTERESTED IN WORKING WITH US ON THIS INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392637 | VIDEO DUODENOSCOPE | DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FDT | PENTAX OF AMERICA, INC. | ED-3490TK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| O| R |