MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number TJF-Q190V

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

As part of the olympus 522 post market surveillance study, the distal end of the evis exera iii duodenovideoscope was microbiologically cultured and tested positive for escherichia coli (e.Coli) too numerous to count.After a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, and post reprocessing, samples were collected and sent to an independent laboratory for testing.No patient injury reported.

Manufacturer Narrative

A visual inspection of the scope for clinical sampling was performed by the facility.The forceps elevator and body surface around the elevator had no visible debris.The objective lens and light guide lens at the distal end of the insertion section had no residue or stains and no scratches or cracks.The glue around the lenses was not discolored or pitted and the glue was not peeling or chipping.The air water nozzle at the distal end of the insertion section did not appear damaged and there was no visible debris.The distal ring at the distal end of the insertion section had no cracks or dents on the ring.The glue around the ring was not discolored or pitted and the glue was not peeling or chipping.The white isolation block at the distal end of the insertion section did not have any cracks or dents.The surface of the distal body at the distal end of the insertion section had no corrosion and no debris.The glue condition around the left side surface of the distal end was not discolored nor pitted, had no cracks, and had no peeling or chipping glue.The facility reprocessed the scope in a steris ie automatic endoscope reprocessor (aer).Sampling of the scope for culture testing was performed by the facility.All personal protective equipment was worn.The sampling was pre-disinfected using provided disinfectant.All the necessary supplies were aseptically placed in the sterile field.No defects were in this sample collection container and solution.No other person other than olympus staff entered the sampling area.The distal end was inspected.No visible debris was observed.The correct surfaces of the distal tip were swabbed.The correct areas of the elevator recess were brushed and flushed.The instrument channel was brushed and flushed.No significant deviations were observed in regard to aseptic or sterile techniques during sampling that could have contaminated the sample.All the correct sterile components and materials were used.No sampling instruments touched any non-sterile areas or surfaces besides the scope.No gloved hands made any contact with non-sterile surfaces.The scope was properly dried using filtered compressed air after sampling was completed.An olympus endoscopy support specialist (ess) visited the customer on (b)(6) 2023, to perform an observation of the reprocessing techniques.The ess noted no deviations during reprocessing, however the facility performed delayed reprocessing since the scope in question did not receive attention overnight.The department used medivator scope buddy plus for suction and channel flushing and used the steris 1e automated endoscope reprocessor for disinfection and rinsing.The ess could only confirm that the scopes were placed in the unit and that a test strip was included.The test strip provides efficacy information post reprocessing cycle.Steris would need to validate usage and provide instructions for use.The subject device referenced in this report was not returned for evaluation but was sent to an independent laboratory for destructive sampling.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

Corrected data: d9, h3 and h6 (updated to 10 ¿ testing of actual/suspected device).This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for evaluation after desctructive sampling.The forceps elevator/lever wire was cut.The plastic distal end cover body was damaged, and the arm and arm cover were missing.The nozzle, bending section cover, and bending section cover glue were missing.The scope leak check, plastic distal end cover insultation, guide wire tension test, and catheter test could not be performed due to missing parts.Play was found on the control knob, there was a missing hold ring, there was a large chip in the light guide lens, the bending section cover glue was discolored and cracked and the insertion tube was peeling, a review of the device history record found no deviations that could have caused or contributed to the reported issue.Escherichia coli is a facultatively anaerobic, gram-negative bacillus which commonly resides within the lower intestines of all humans and many other mammals.Due to their typically benign status as a commensal organism, they can be commonly recovered from the oral cavity and throat as well.This species has presented a high degree of adaptability to many environments and as a result, certain strains can become an opportunistic pathogen under the right conditions.E.Coli has been connected to numerous outbreak scenarios in the realm of gastrointestinal health.There was delayed reprocessing as the scope sat overnight and soaked the next morning for 2 to 4 hours.The endoscope did not show deviations / non-conformities during visual inspection during the sampling process.All 12 required scope sampling points were sampled.Growth was recovered from 3 out of 12 sampling sites.The microorganism identified during destructive sampling did not match nor confirm the originally identified escherichia coli.Instead, the destructive sampling cultures identified environmental and skin contamination.Escherichia coli is identified as a hc organism per the olympus protocol and fda definitions for this 522 study.Based on the sponsor¿s literature research, escherichia coli has been described in literature as being associated with contamination or patient infection related to ercp.Due due limited information surrounding the site¿s delayed reprocessing, the investigation was unable to determine the cause of contamination.However, this site has confirmed, in cases where reprocessing delays exceed 60 minutes, their internal procedure involves soaking scopes for 2-to-4 hours.Since this scope sat overnight in an un-reprocessed condition, that could have contributed to a high bioburden load.In addition to the delayed reprocessing, the site declined to be audited on pre-cleaning steps and undergo additional training.Additionally, the site¿s use of an aer that does not perform an automated cleaning cycle places more emphasis on the manual cleaning being performed properly.This could have allowed contaminants to proliferate and survive the reprocessing cycle : this sample cannot be excluded as having a relationship to patient use.An insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.This report will be supplemented if additional information becomes available at a later date.Olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16859916
• MDR Text Key: 314455575
• Report Number: 9610595-2023-07034
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170452024
• UDI-Public: 04953170452024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Device Catalogue Number: N5992941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2020
• 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 Sex: Unknown