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

Model Number BF-1T180

Device Problems Biofilm coating in Device (1062); Loose or Intermittent Connection (1371)

Patient Problems Bacterial Infection (1735); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The scope was returned to the service center however the investigation is ongoing.A review of the service history of the scope indicates the scope was purchased on (b)(6) 2009 and there are four repairs in the past three years.The last repair involved a loose biopsy port.In addition, an endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed that the scope's biopsy port was noted to be loose.The biopsy port was reportedly taken apart and foreign residue was present.There was no patient injury reported, however, the user facility reported the scope was linked to two cases of possible contamination.This is for 2 of 2 reports.

Event Description

The service center was informed by the clinical nurse manager at the user facility further reported that were was a possible contamination issue as three different patients that had undergone bronchoscopy (with navigation) procedures were cultured via aerobic culture and gram stain broncho alveolar lavagepositive and were positive for a "light" growth of serratia marcescensgram.It was reported one scope was involved.Additionally, the user facility reported the biopsy port at the proximal end of the scope was noted to be loose.The biopsy port was reportedly taken apart and foreign residue was present.The user facility had not cultured the referenced scope and the scope was returned to the service center for evaluation.The clinical nurse believes contamination of specimen was the cause of the patients' outcomes.This report is for patient# 2.

Manufacturer Narrative

Regarding the reprocessing, the scope is pre-cleaned immediately following navigation procedure.Then scope is stored in a clean cabinet until ready to perform navigation.The endoscope is leak tested prior to manual cleaning and the endoscope channel is brushed during manual cleaning.The cleaning/disinfectant solution's minimum effective concentration are checked every wash cycle.There has not been any problem noted with the automated endoscope reprocessor (aer)machine.There is no manual flushing of air into the channel of the endoscope after reprocessing as the aer machine flushes air at the end of the cycle.The last time a reprocessing in-service reprocessing was provided was september 2018.There has been changes to the reprocessing personnel since then.All of the reprocessing personnel have been properly trained on how to reprocess an endoscope.The scope is stored in a self-ventilated/clean scope cabinet.An endoscopy support specialist (ess) visited the user facility on december 5, 2019 and performed a cleaning in-service with the staff.In-services included all the cleaning and disinfecting information contained in the olympus manual.An observation of facility's reprocessing practice was not performed.However, the ess did emphasize to the staff to always check that the biopsy port is intact and not loose prior to use.The scope was returned to the service center and was forwarded to an independent laboratory for microbial testing; results are pending.The cause of the reported event cannot be determined as the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.Please reference the related internal complaints, importer mfr report numbers.((b)(6) / patient 1 2951238-2019-03710, ((b)(6) / patient 2) 2951238-2019-01225 and ((b)(6) / patient 3) 2951238-2019-01219.

Manufacturer Narrative

The scope was sent to an independent laboratory for microbial testing.The scope's instrument/suction channel tested positive for serratia marcescens.The scope was ethylene oxide (eto) sterilized and returned to the service center for a physical evaluation.A visual inspection was performed on the scope's instrument and suction channels.Scratch marks were noted inside the instrument channel from the biopsy port side.There were kinks observed inside the instrument channel from the distal bending section side.There was no evidence of foreign material or residue inside the channel or at the biopsy port.The scope passed the leak test.The service group noted the biopsy port was loose and the bending section was dented.In addition, the glue inside the channel at the distal end cover side was peeling.The scope was repaired and returned to the user facility.Based on the investigation, the cause of the reported positive patient and scope cultures could not be conclusively determined.However, the clinical nurse manager reported pre-cleaning is not performed immediately after a procedure, as the physician uses scope for airway evaluation, then scope is stored in a clean cabinet until ready to perform navigation.The scope is pre-cleaned immediately following navigation procedure.As a preventive measure, the reprocessing manual provides warning and cautions that states, if the endoscope is not immediately cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.All channels of the endoscope must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.

• 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
• MDR Report Key: 9238618
• MDR Text Key: 202877884
• Report Number: 8010047-2019-03711
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1T180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 70% ISOPROPYL ALCOHOL.; AER: OER PRO S/N (B)(6) AND (B)(6).; FIRST STEP-PRE CLEANING KIT ENZYMATIC DETERGENT.; MEDIVATOR CHANNEL CLEANING BRUSH#100402.; MEDIVATOR/VERISCAN LEAK TESTER.; OLYMPUS ACECIDE-C.; OLYMPUS ENDOQUICK-ALKALINE DETERGENT.; TERGAL 800 DETERGENT.
• Patient Age: 77 YR
• Patient Weight: 97