MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-PRO ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

As part of our investigation on july 21, 2016 an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess and observe the account¿s reprocessing practices.The ess noted no deviation with facility¿s reprocessing methods, however the oer-pro automated endoscope reprocessor (¿aer¿) was found to be cosmetically in poor condition with calcification residue observed within the aer reservoir basin.The ess noted that the tubing sets to the aer were raveled in a pile and recommended that they be hung to ensure proper drying.On july 22, 2016 the ess reviewed his findings with an olympus field service engineer (fse) regarding the residue observed in the aer basin.On august 1, 2016 the fse was dispatched to the user facility to review the facility¿s maintenance of the four oer-pro aers.The fse reported that the internal pumps and tubing of the aers were in adequate condition; however there was calcium build-up in all of the aer basins.The fse observed a yellowish-calcified foreign material in the basin on the aer (oer pro, serial number (b)(4)).The fse reported that the facility routinely disinfects the water supply line and replaces the water filter every six months as recommended in the oer-pro ifu.As part of our investigation, the foreign material in the basin will be sampled and sent to an independent laboratory for further testing and culturing.Due to the ongoing investigation, the olympus fse recommended that the user facility refrain from using the oer pro (serial number (b)(4)) until the test results are received.Olympus cannot determine the cause of the reported event, but the condition of the returned bronchofibervideoscope cannot be ruled out as a contributing factor.Endoscopes that fail leak testing can pose an infection control risk.The instruction manual contains several warning statements in an effort to prevent severe equipment damage and patient injury: ¿in addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically.An endoscope with an observed irregularity should not be used, but should be inspected by following section 10.1, ¿troubleshooting guide¿ on page 141.If the irregularity is still suspected after inspection, contact olympus.Using an instrument that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.¿.

Event Description

On july 08, 2016 olympus received a medwatch report (mw5062993) which indicated that there were 12 cases of isolation of candida lipolytica from either a patient's lymph node or respiratory specimen obtained bronchoscopically during an endoscopic transbronchial lymph node biopsy or a therapeutic bronchoscopy between december 30, 2015 and july 06, 2016.The facility reported that there were five ultrasound bronchofibervideoscopes (model: bf-uc180f) and three bronchovideoscopes (model: bf-1th190) utilized during this time period.The facility reported that seven of the eight selected scopes were cultured in (b)(6) 2016 and the eighth scope in (b)(6) 2016 according to cdc interim recommendations for culturing duodenoscopes.The eight devices were reported as negative for bacterial and fungal growth.On july 13, 2016 the facility reported that there was an additional 13th patient identified with positive culture for candida lipolytica from either a lymph node or respiratory specimen that was obtained bronchoscopically during an endoscopic transbronchial lymph node biopsy or a therapeutic bronchoscope between december 30, 2015 and july 06, 2016.On july 29, 2016 the facility reported a 14th patient identified with a specimen that cultured positive for candida lipolytica on (b)(6) 2016 after undergoing a procedure on (b)(6) 2016.Additionally, on july 29, 2016 the facility reported that from the end of january 2016 to may 2016, an additional 19 patients were identified as having "yeast forms" however; the patient specimens were not cultured to confirm candida lipolytica.There was no evidence of clinical infection associated with any of these cultures or patients.The user facility alleges that the source of growth is likely from a persistent microbial contamination of one or more oer pro aers with candida lipolytica due to the filtered potable water source and the persistence of biofilm.The facility alleges that all the scopes were reprocessed predominantly in one of six aers at the facility (model: oer pro, serial number(b)(4)).Which included each of the first seven positive cultures identified.The user facility reported that after the oer-pro annual preventative maintenance in february 2016, the serviceable parts were cultured and all samples were reported negative for growth.The facility alleges that during this time there were three other aers used to reprocess the scopes before a procedure.Reportedly all 13 scopes remain in clinical use.

Manufacturer Narrative

This supplemental report is being submitted as additional information to report the independent laboratory results.As part of our investigation, the foreign material in the oer-pro basin was sampled and sent to an independent laboratory for analysis and culturing.The fourier transform infrared spectroscopy (ftir) analysis and the culture were negative for any protein material or fungal growth, respectively.

Manufacturer Narrative

This supplemental report is being submitted to report additional information received from the user facility.Olympus was informed of new information of five cases of isolation of candida lipolytica from either a patient¿s lymph node or respiratory specimen obtained bronchoscopically during an endoscopic transbronchial lymph node biopsy or a therapeutic bronchoscopy.The user facility reported that a total of 18 patients have been identified with this organism since december 2015.The facility reported that there were three ultrasound bronchofibervideoscopes (model: bf-uc180f) and one bronchovideoscopes (model: bf-1th190) utilized during this time period.The facility reported that scopes were cultured according to cdc interim recommendations for culturing duodenoscopes.The devices were reported as negative for bacterial and fungal growth.The facility alleges that the four scopes were reprocessed utilizing four of the six aers at the facility.Additionally, the user facility reported that it was believed that the municipal water supply that was used in the facility¿s aers could be the source of the microorganism.This prompted the facility to perform an investigation and on august 30, 2016, the facility reported that 1 liter samples of filtered potable or municipal water was collected from each of the four aers prior to use.These specimens were plated to blood and inhibitory mold agars that were held at 25 degrees c for 2 week.The facility reported that on september 14, 2016 the culture results were finalized and found the blood plates were overgrown with environmental bacteria (bacillus species) and the inhibitory mold agar were overgrown with a variety environmental molds such as aspergillus and penicillium.There were no c.Lipolytica isolated due to over-growth; however, it is possible that the microorganism was there but was unable to be recovered.Please cross reference the following mfr.Report numbers: 2951238-2016-00840, 2951238-2016-00842, 2951238-2016-00843 and 2951238-2016-00844.

• Brand Name: OER-PRO ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5848886
• MDR Text Key: 51231729
• Report Number: 2951238-2016-00647
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: OER-PRO
• Device Catalogue Number: OER-PRO
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/23/2016; 11/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other