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

Model Number CF-H180AL

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

Patient Problem Unspecified Infection (1930)

Event Date 12/17/2017

Event Type  Injury  

Manufacturer Narrative

The subject scope has not been returned for evaluation.The user facility noted the scope would be sent to an independent laboratory for culture testing.To date, no additional information has been received.The user facility reported that the scope was sent in for repair after the december procedure and had a leak.The scope was repaired and returned at that time.As part of our investigation, an endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facilities reprocessing practice and to provide a reprocessing training.The ess observed following deviations: during leak testing procedure, angulating of the bending section and proper removal and disconnection from the mu-1 device.During manual cleaning, there is deviation in the order of brushing and how many times the steps are being performed with the scope out of the detergent solution.There was several occasions where the channel opening was brushed first, followed by the suction channel.In addition, there was inconsistent drying of the scope before placement in the aer.The user facility acknowledged the improvements needed in the reprocessing steps and will conduct competency checks on staff more often ess also conducted in-service which included leak testing, manual cleaning, disinfecting, sterilization and storage information contained in the reprocessing manual.The cause of the patient infection cannot be confirmed, however, if additional information becomes available or if the scope is returned at a later date, this report will be supplemented accordingly.As a preventive measure, the scope's reprocessing manual provides warning to mitigate the risk of patient infection which states: all disinfection methods (whether performed manually or by an automated endoscope reprocessor), and all sterilization methods (whether performed by ethylene oxide gas or steam) require thorough prior cleaning of the instrument being reprocessed.If the equipment is not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective.Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope and the accessories used with the endoscope.All channels of the endoscope, including the instrument channel and the auxiliary water channel, and all accessories used with the endoscope during the patient procedure, such as all valves and the auxiliary water tube (maj-855), must be cleaned and high-level disinfected or sterilized after each patient procedure, even if the channels or accessories were not used during the patient procedure.Insufficient cleaning and disinfection or sterilization of these components may pose an infection control risk to patients and/or operators.

Event Description

The manufacture was informed that after a colonoscopy procedure on (b)(6) 2018, the patient ¿s urine tested positive for carbapenem-resistant enterobacteriaceae (cre) sometime in (b)(6) 2019.

Manufacturer Narrative

The model number was corrected (d4).The user facility sterilized the scope and returned the scope to the service center for evaluation.A visual inspection was performed on the scope and was there were no signs of foreign substance/stain inside the instrument channel/port, and suction/port.However, there were scrape marks inside the instrument channel wall at the distal bending section side.Additionally, there were no signs of foreign substance/stain found with the external areas of the scope (insertion tube, bending section cover or distal end.The scope failed the leak test from the scope connector and at the bending section cover (hole/cut).The service group noted the distal end cover has deep dents and the bending section cover glue is cracked.The cause of the damage to the bending section cover/glue and distal end cover was potentially attributed to stress from excessive force/impact.A review of the service history of the scope found ten repairs in the past three years; none involving patient infection or a cross contamination issue with the scope.Based on the evaluation and investigation, the cause of the reported patient infection could not be determined as there was no abnormalities or foreign material/stain found on the scope.

Manufacturer Narrative

This supplemental report is being submitted to provide additional from the user facility and to update the following sections: a2, a3, a4, b7, e2, e3, e4, g3, g4, g7, h2, and h10.The endoscopy central manager at the user facility further reported there was only one patient infection reported to have cre.The cause of patient infection is unknown.The patient's urine specimen was taken on (b)(6) 2019 at primary care provider (pcp); patient asymptomatic.The infection was detected on (b)(6) 2019 and reported to pcp.Tennessee department of health (tndoh) contacted gastro one department on (b)(6) 2019.The scope was quarantined and out of service since notification the afternoon of (b)(6) 2019.The scope will be sent to an independent lab for culture testing.On (b)(6) 2019, the endoscopy central manager informed received the culture test results for the scope and indicated there was no cre detected.However, the scope cultured positive for bacillus pumilus; could be a culture contaminant.The facility plans to send the scope out for ethanol sterilization to eradicate the bacillus in case it is from the scope and then send the scope to the manufacturer for a physical inspection.Additional information regarding the reprocessing.Precleaning is perfomed immediately after a procedure.There are no reported issues with the automated endoscope reprocessor machine (aer) and the minimum effective concentration of the disinfectant solution is checked prior to each scope going through the aer.The scopes are vertically hung in scope cabinet.There has been no changes to the reprocessing staff since the last endoscopy support specialist in-service visit on (b)(6) 2018 and all reprocessing staff are trained.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8683917
• MDR Text Key: 147500912
• Report Number: 2951238-2019-00926
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170202506
• UDI-Public: 04953170202506
• Combination Product (y/n): N
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CF-H180AL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AER: MEDIVATOR DSD SN (B)(6); CHANNEL BRUSH: OLYMPUS BW-412T; CLEANING SOLUTION: INTERCEPT DETERGENT 60ML; DISINFECTANT SOLUTION: RAPICIDE; LEAK TESTER: OLYMPUS MU-1; SCOPE LOCKER: MASS MEDICAL.
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 64