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.

• 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 965-8 520; JA 965-8520
• 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
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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