MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERAII BRONCHOVIDEOSCOPE

Model Number BF-Q180-AC

Device Problems Contamination (1120); Crack (1135)

Patient Problem Respiratory Tract Infection (2420)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation, although it is anticipated to be shipped back for 3rd party culturing.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.The customer reported internal investigation findings: it was discovered, at the end of each bronchoscopy procedure, tap ice water is being injected through the scope with a syringe with the aim of reducing post-procedure bleeding.Culture results of the water supply are: we had them run 2 tests the heterotrophic plate count (hpc) and a total coliform e.Coli test.The water was not tested for the specific organism identified in the patient cultures.The total coliform e.Coli test was negative, the hpc test had a count of 214 cfu.The water company came to culture the ice machine and said they couldn't do it because the ice machine was off.So, they cultured the water from the sink next to the ice machine which has the same water source.Then we turned on the ice machine to have it cultured, but for some reason i don't know, it wasn't cultured.Only the water source for the ice machine.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238 - 2021 - 00308.

Event Description

It is reported 48 days post bronchoscopy procedure for the indication of chronic cough with abnormal ct, and personal history of lung cancer using an evis exera ii bronchovideoscope, the patient developed a respiratory tract infection with mycobacterium llatzerense.This was diagnosed with bronchial alveolar lavage (bal).It is unknown what treatment the patient required as a result of this infection.The patient died 28feb2021 from pre-existing comorbidities.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in b1, d9, h3, h4, h6, and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Physical evaluation of the complaint device: the bf-q180-ac video scope (serial number confirmed) was received by olympus for evaluation due to "positive culture".Olympus performed a visual inspection on the received condition.The biopsy channel was inspected with an olympus boroscope.Olympus noted numerous scrape marks within the channel, beginning at the distal end opening that proceed to the middle of the insertion tube.There were no stains, or foreign material discovered within the biopsy channel.Additional findings include chips and open bending section cover glue on both ends.The light guide lens has some deterioration leading to damaged glue surrounding the lens.The gold ring near the s-cover is fading.The video scope passed the water leak test inspection.The water leak test inspection was performed by submerging the video scope into a basin/tub filled with water, while being connected to a regulated airline.The scope was submerged for approximately ten minutes, with no signs of leakage occurring.Further, the video scope was purchased on the 16th of november 2019.There are no service events since the purchase date.Scope culture findings from third party testing facility: biopsy channel: staphylococcus aureus.Distal end: not detected.Mycobacterium llatzerense, detected from bal sample of patient was not detected from the device.Conclusion: the definitive cause of the reported events could not be established.We presume from the following factors that the patient infection occurred by contamination of ice water, which was used at the end of the procedure.It is possible that the ice machine at the user facility may have been contaminated.Therefore, the water from the contaminated ice machine may have caused the germ detection from biopsy channel of the scope when cultured.

Manufacturer Narrative

This mdr is being submitted as a result of a complaint retrospective review.Reprocessing steps of the subject device at the user facility were provided where: 1 immediate enzymatic detergent cleaning of the external body and pulled through channels.2 taken to reprocessing room for immediate reprocessing.3 dry leak test.4 cleaned external and internal for bioburden with enzymatic detergent.5 resi test done to check for residual bioburden.6 taken to oer for hld high level disinfect.7 taken out of oer and laid on counter for air blown through all channels until residual water is evaporated.8 hung up vertical in our scope hang room until needed for procedure.Conclusion: (suggested event 1: suspicion of cross-contamination).We could not specify relation between the suggested event 1 and the device from the following investigation results: mycobacterium llatzerense was not detected in the culture test of the subject device.The physiological saline used in the case was negative in the total e.Coli test, and was confirmed to be below the standard value set by the cdc (214 cfu / ml) in the number of general bacteria: hpc (heterotrophic plate count).Since the ice machine had been disinfected, the ice water culture test used to cool the syringe containing saline in the case could not be performed.The bal sample of the patient of the case that used model: bf-q180, serial: (b)(4) with ice water from another ice machine in the day before the event was used was negative.No obvious deviation from ifu was confirmed from the review of the reprocessing steps at the user facility.(suggested event 2:positive culture test).We could not specify relation between the suggested event 2 and the device from the following investigation results: as the result of the culture test of the subject, staphylococcus aureus was detected from biopsy ch.There were numerous scrape marks within the biopsy channel.Since the ice machine had been disinfected, the ice water culture test used to cool the syringe containing saline in the case could not be performed.No obvious deviation from ifu was confirmed from the review of the reprocessing steps at the user facility.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERAII BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11597196
• MDR Text Key: 246578914
• Report Number: 8010047-2021-04429
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170340086
• UDI-Public: 04953170340086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BF-Q180-AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2019
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 66 KG