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

Model Number PCF-H190DL

Device Problem Device Rinsing Issue (2309)

Patient Problems Fever (1858); Inflammation (1932)

Event Date 04/18/2016

Event Type  Injury  

Manufacturer Narrative

As part of our investigation into this report, olympus dispatched an endoscopy support specialist (ess) and field service engineer (fse) to the facility to observe their reprocessing practices and further evaluate the oer-pro.Fse visited the facility on 4/20/2016 and performed system diagnostics for the oer-pro, but no anomalies were identified during the evaluation.The facility was informed of the oer-pro onsite evaluation results.Ess visited the facility on 4/25/2016.No deviations were immediately observed when scopes were placed in the oer-pro.However, the facility was informed of the importance of diligent leak testing and not leaving the oer-pro connectors in the systems that are not connected to scopes and being used.The facility was reminded of the importance of testing the chemical cleaning agent (acecide) before every cycle.The scope was returned to olympus for evaluation.Yellow colored debris and a stain were found at the distal end of the scope after passing a brush through the biopsy channel.No restrictions were noted when passing a brush through the biopsy channel.Visual examination of the biopsy and suction channels with an olympus borescope found scrapes and yellow stains in the biopsy channel wall at the bending section area, approximately 25 mm from the distal end.No stains or scratches were observed inside the suction channel wall.The scope also passed leak and pressure testing performed.The scope was sold on 12/09/2015 and has accumulated 55 uses.Based on the condition of the biopsy channel, the most likely cause is due to improper reprocessing and insufficient rinsing/flushing of the channels.The scope was returned to the facility unrepaired as per the customer's request.The facility requested olympus to assist with forwarding the scope to an independent microbiology laboratory for bioburden testing, per the customer's request.

Event Description

Olympus was informed that a patient developed chemical colitis following a colonoscopy procedure.The patient experienced fever and left lower quadrant pain and returned to the er and was discharged within a few hours.The patient was treated with antibiotics and is recovering.The scope was reprocessed in an olympus oer-pro using acecide as a cleaning solution.The facility suspects that internal damage to the scope may have led to retention of acecide.

Manufacturer Narrative

This supplemental report provides microbiology testing results, device re-evaluation and additional updates.The microbiology testing found the scope tested positive for staphylococcus hominis (gram positive cocci).The device was returned to olympus for re-evaluation.Visual examination of the biopsy channel with an olympus boroscope confirm scrapes and brown stains on the channel walls.The evaluation performed in april 2016 found foreign debris inside the suction channel.When the suction channel was re-examined, no signs of foreign material or stains were observed.No visual signs of foreign material were found at the distal end cover, nozzle, light guide lens, objective lens, bending section cover glue, or insertion tube.The scope again passed leak and pressure tests.No other abnormalities were identified during the re-evaluation.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 5651901
• MDR Text Key: 45092331
• Report Number: 2951238-2016-00426
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190DL
• Device Catalogue Number: PCF-H190DL
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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