MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE; FLEXIBLE VIDEO GASTRODUODENOSCOPE

Model Number	GIF-N180
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following patient identifiers are related to each other: (b)(6) (model number enf-vh - rhino-laryngo videoscope: serial number (b)(4)), (b)(6) (model enf-v3 - rhino-laryngo videoscope : serial number (b)(4)), (b)(6) - model gif-n180 - evis exera ii gastrointestinal videoscope : serial number (b)(4)) and (b)(6) (model oer-elite - endoscope reprocessor).When speaking to the olympus endoscopy support specialist (ess), the reprocessing technicians explained this was occurring because the scopes were just ¿expired¿ scopes that needed to rerun and were ¿clean.¿ it was further explained that at this time, there was not a way to scan enf scopes into the elite for the reprocessor to run, which was why the enf scopes were with the gif scope.The endoscopy support specialist (ess) instructed the reprocessing technicians that it was against the elite¿s instructions for use (ifu) to reprocess three (3) scopes at once.Additionally, enf scopes are not compatible to run in the oer-elite with gif scopes.A quote was made for the radio-frequency identification (rfid) tags to be made for the scopes to run in the elite by themselves.Ess relayed this information to the management at the user facility.The ess ensured the scopes that were placed in the elite were re-high-level disinfected (hld) properly.The customer has a back up plan until the rfid tags come in to hld soak in cidex.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The endoscopy support specialist (ess) reported that while performing reprocessing training on the tjf-q190v scope, the ess observed that the customer site was washing three (3) scopes (enf-vh, enf-v3 and gif-n180) in the oer-elite instead of the recommended two (2).There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
Device available for evaluation - yes was inadvertently selected on the initial report.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified; however, it is likely that there was a difference in the handling of equipment and recognition of reprocessing procedures between olympus' recommendations and the facilities concerned.The event can be detected/prevented by following the instructions for use (ifu) which state: "an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them." also included in the ifu is a list of compatible endoscopes/connecting tubes which describes a list of scopes that can be reprocessed at the same time.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: FLEXIBLE VIDEO GASTRODUODENOSCOPE
• 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: 15955274
• Report Number: 9610595-2022-05215
• Device Sequence Number: 17806104
• Product Code: FDS
• UDI-Device Identifier: 04953170339080
• UDI-Public: 04953170339080
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: GIF-N180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENF-V3 SERIAL NUMBER (B)(4); ENF-VH SERIAL NUMBER (B)(4); OER-ELITE
• Patient Sex: Unknown