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Model Number TJF-160VF
Device Problem Device Reprocessing Problem (1091)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative

No specific serial numbers were provided for the scopes used during the procedures; therefore, it is unknown if the scopes were returned to olympus for evaluation and service. Olympus followed up with user facility by telephone and in writing in an attempt to gather more detailed information regarding the adverse events but with no results. As part of our investigation, on december 11, 2018 an olympus endoscopy support specialist (ess) and regional service director visited the user facility to observe the facility¿s reprocessing practices and provide training if necessary. No in-service was provided during this visit; however, the ess and regional service director were able to observe the user facility¿s sterile room or reprocessing room and noted that three endoscopes sat for at least 30 minutes awaiting leak testing and manual cleaning. The ess was then informed by the director of nursing (don) that in the past three months there had been a high turnover with their reprocessing staff. Also, the medivators automated endoscope reprocessor (aer) machine that was used to reprocess the scopes was noted to have issues in (b)(6) 2018. The ess informed the don was informed that there had been a delay of scope reprocessing noted in a previous visit. The nursing director stated that this was not a concern, as the reprocessing staff was aware of the delayed reprocessing instructions. In addition, the ess reported that the reprocessing staff was reminded to properly clean/disinfect or sterilize the olympus accessories, such as the injection tubing (maj-222), and suction cleaning adapter tubing (mh-856), as this reprocessing deviation was also noted during a previous site visit. At the conclusion of this visit, the ess recommended that the reprocessing staff order sufficient cleaning adapter tubing. On december 13, 2018, the ess provided an in-service to the user facility¿s nursing staff. The in-service was focused on performing proper pre-cleaning of tjf-160vf and gf-uct180 eus scopes only. During the in-service, the ess noted the staff is using scope buddy (medivator machine) during periods of high volume the user facility may run out of air/water cleaning adapters and suction cleaning adapters. When this occurred, the reprocessing staff would skip these steps and continue without the use of any cleaning adapters. The suction adapters were not properly cleaned and were placed loosely inside the medivators aer. Following procedures, the used scopes sat for an extended period of time without undergoing an extended soak as per the delayed reprocessing instructions. The reprocessing staff carried more than one scope in the same hand without the use of protective gloves. In addition, the scopes were stacked by twos in a tub and transported. Please also cross reference mfr. Report numbers: 2951238-2019-00293, 2951238-2019-00294, 2951238-2019-00295, 2951238-2019-00296, 2951238-2019-00297, 2951238-2019-00298, 2951238-2019-00299, 2951238-2019-00300, 2951238-2019-00301, 2951238-2019-00302, 2951238-2019-00303, 2951238-2019-00304, 2951238-2019-00305, 2951238-2019-00306, 2951238-2019-00307, 2951238-2019-00308, 2951238-2019-00309, 2951238-2019-00310, 2951238-2019-00311, 2951238-2019-00312, 2951238-2019-00313, 2951238-2019-00314, 2951238-2019-00315, 2951238-2019-00316, 2951238-2018-00824, 2951238-2018-00825, 2951238-2018-00826, 2951238-2018-00827 and 2951238-2018-00820.

Event Description

Olympus was informed that three additional patients were identified to have developed carbapenem-resistant enterobacteriaceae (cre) infections since august of 2018 after undergoing ercp procedures at the user facility. It was reported by the facility¿s staff that scopes have been observed sitting for over one-hour before being pre-cleaned. The facility¿s scopes are repaired by a third party. The course of treatment and the current condition of these patients is unknown. Previously, on december 10, 2018, olympus was informed was informed that the user facility had experienced an outbreak between 2013 and 2016 in which 19 patients developed drug resistant organisms and one patient expired (patient 1) after undergoing endoscopic retrograde cholangiopancreatography (ercp) procedures using a duodenoscope. Reportedly, the patients also developed sepsis and liver abscess during this time. The user facility reported that patient 1 presented to the facility on (b)(6) 2016 and was found to have a fever and cholangitis. On (b)(6) 2016 a sample was taken from the patient via ercp and cultured positive for enterococcus faecium, vancomycin resistant (vre). Further culturing was performed on (b)(6) 2016 and the patient¿s blood tested (b)(6) for (b)(6). The patient subsequently developed a stroke and expired. Additionally, the user facility reported that since august of 2018 there have been eight more patient infections and one patient death (patient 2) after ercp procedures due to drug resistant organisms such as: enterobacter, vre and cre. The user facility reported that patient 2 presented to the user facility on (b)(6) 2018 with a common bile duct stone and ruq pain that was treated with ercp and cholecystectomy. The patient developed pancreatitis and cholangitis shortly after the procedure. On (b)(6) 2018 the patient¿s blood culture tested positive for carbapenem-resistant enterobacteriaceae (cre) and e coli resistant organisms. The patient was seen by the facility¿s infection & disease team and plethora of specialists at the facility. The patient developed hypotension and necrosis of all limbs which resulted in a loss of multiple fingers and toes. The facility reported that the patient continued to have issues with organ failure and recurrent sepsis. The patient subsequently expired in late (b)(6) 2018 due to failure of the liver. The course of treatment and current conditions of the remaining 27 patients is unknown. Medical device reports were previously submitted to account for these events. As a result of the patient infections and two patient deaths the facility¿s physicians believe that a delay in the pre-cleaning of the facility¿s ercp scopes maybe a contributing factor. According to the user facility the texas health department inspected the facility¿s gi lab and found no abnormalities; however, the facility¿s pre-cleaning was not observed. It was reported that since the visit a gastroscope was recently cultured and tested positive for an unknown organism. The scope is currently quarantined at the user facility. This 1 of 3 reports.

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Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
MDR Report Key8379810
MDR Text Key137465011
Report Number2951238-2019-00470
Device Sequence Number1
Product Code FDT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK024033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 02/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device MODEL NumberTJF-160VF
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Date Received: 02/28/2019 Patient Sequence Number: 1