MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA LLL COLONOVIDEOSCOPE

Model Number PCF-H190L

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

Patient Problem Bacterial Infection (1735)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus for evaluation.A review of the instrument¿s history was performed and found that the device had not been returned for service/ repair since the date of purchase on february 24, 2015.The cause of the reported event cannot be determined at this time.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event.If additional information becomes available, this report will be updated and supplemented accordingly.

Event Description

Olympus was informed that two patients developed a carbapenem-resistant enterobacteriaceae (cre) infection after undergoing unspecified procedures using the colonovideoscope in (b)(6) 2018 and (b)(6) 2018.The patient¿s course of treatment is unknown.In addition, the user facility reported that the colonovideoscope was sent to a third party for culturing and tested negative for growth.This is report 1 of 2.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Olympus received additional information that states patient 1 was underwent both upper/lower endoscopy on (b)(6) 2018 over the course of a couple of days.The patient¿s urinalysis was positive for the new delhi strain of cre at a week post procedure.Patient 2 had an upper endoscopy performed on (b)(6) 2018 and tested positive for cre.Both patients were treated with antibiotics.According to the facility¿s director of perioperative services the state is linking these cases to a rehabilitation/nursing facility within 20 miles of this hospital.The state is also requesting that the facility send these three scopes out to be cultured.Additionally, the user facility reported that their scopes are pre-cleaned using intercept enzymatic.The scope is leak tested prior to manual cleaning, the endoscope channel is being brushed during manual cleaning, the facility utilizes single use brushes.The scopes are reprocessed using the medivators dsd and medivators dsd-201 with rapicide (sn# (b)(4) and (b)(4)).Then stored in a hanging cabinet.The facility's last in-service with an olympus ess was performed back in july 2018.The facility reports that there has been no change to the reprocessing staff since the last in-service and all staff is trained to properly reprocess a scope.

Manufacturer Narrative

This supplemental report is being submitted to provide the independent laboratory results, to provide the evaluation findings.The scope was sent to an independent laboratory for microbial testing.The scope's air/water and instrument / suction channels were cultured and tested positive for the following microbial organisms: bacillus simplex and staphylococcus epidermidis.The scope was then ethylene oxide (eto) sterilized and returned to olympus for a device evaluation.Olympus performed a visual inspection on the colonovideoscope and found black marks inside the instrument channel from the biopsy port side when inspected with an olympus borescope.A red stain was noted inside the suction channel from the scope connector side.Further inspection of the instrument channel found yellowish discoloration inside the outer walls from the bending section side.There were no signs of kinks, marks, or damages on the suction channel and instrument channel.Additionally, the image was inspected and the image of the scope is normal.The scope passed leak testing.

Manufacturer Narrative

Additional information received from the user facility states that patient 2 was examined with two additional scopes during their procedure in october 2018.A third patient's post urinalysis has also cultured positive for same new delhi strain of (cre) after undergoing an upper endoscopy procedure on december 13, 2018 using a gif-hq190 (sn.(b)(4)).This patient was also treated with antibiotics.As part of our investigation, on december 5, 2018 an olympus endoscopic support specialist(ess) was dispatched to the user facility to observe the user facility¿s reprocessing practices and provide training if necessary.The ess noted the following reprocessing deviations: steps were missed, improper use of cleaning adapters and cleaning brush, cinch sacks were being used to transport dirty scopes and no gloves were used during the transportation of clean scopes.An in-service to review the proper reprocessing methods will be scheduled for a later date.This is 1 of 3 reports.Please reference mfr.Report number: 2951238-2018-00748 this is to account for patient 2 who also underwent a procedure with the same scope (b)(4).

• Brand Name: EVIS EXERA LLL COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8143738
• MDR Text Key: 129678357
• Report Number: 2951238-2018-00749
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305191
• UDI-Public: 04953170305191
• Combination Product (y/n): N
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190L
• Device Catalogue Number: PCF-H190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GIF HQ190 /SN. (B)(4).; PCF-H190DL/SN. (B)(4).
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 88