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

Model Number GIF-HQ190

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Nausea (1970); Pain (1994)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number (b)(4).The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.The complaint is related to the following linked patient identifiers: (b)(6).The scope was cultures (results negative) and sent to olympus for full inspection and service.The gastroscope was fully disassembled and all durable components inspected to olympus standards.All non-durable items (gaskets, seals, toric joint/packing joint were exchanged and the insertion tube angulation wires, bending section, air/water connector, and biopsy channel were replaced as part of the standard refurbishment process.Reprocessing: the cleaning and disinfectant solutions used with the endoscope was endoquick (olympus) and acecide (olympus) oer elite model.The minimum effective concentration was checked every time a cycle ran in the reprocessor.The automated endoscope reprocessor (aer) being used to process the endoscope were oer elite by olympus.Serial numbers: (b)(6).The endoscope channel was brushed during manual cleaning.The brush was a single use brush with the model number bw-412-t.A precleaning was being used immediately after a procedure.The endoscope being leak tested prior to manual cleaning with leak tested with veriscan lt.The last preventive maintenance for aer was nov2023.The date of the last reprocessing in-service conducted by an olympus endoscopy support specialist (ess) on 30oct2023.There has been no changes in the facilities reprocessing personnel since the last on-site visit by an olympus ess.All reprocessing personnel trained on how to properly reprocess an endoscope.The endoscope being stored are by forced air drying cabinets.The scope did not have a previous positive culture.The scope was sent out at the request of "ip".It was sent out on 03aug2023 and again on 26oct2023.The patients b and c had two procedures during the timeframe.

Event Description

It was reported that there was a possible patient infection spread through gastrointestinal videoscopescope.Hospital performed an investigation following identification of klebsiella pneumonia positive for new delhi metallo--lactamase-1 carbapenemase (ndm) carbapenem-resistant enterobacteriaceae (cre) from four patients (identified as patients a, b, c, d).Investigation revealed that all four patients had procedures performed within a 37-day period with the same gastroscope.The endoscope was removed from service on (b)(6) 2023 following the matching culture results from patients b and c and the investigation showing patient a had a positive culture with the same organism prior to her procedure.No lapses in endoscope cleaning were identified and there was no report of technical issues with the endoscope.Whole genome sequencing resulted in (b)(6) 2023, showed likely transmission between three patients.This raised suspicion that the scope could be the source, but other epidemiologic links were present.This patient does not share the other epidemiologic links as the other three patient.It has been confirmed that 3 patients have contracted an infection (klebsiella pneumonia, ndm+) following their endoscopic procedure.One of the patients is considered the index patient and had a known history of infection with the same organism (detected (b)(6) 2023) prior to having their endoscopic procedure.The scope has been permanently removed from service.This complaint captures patient d: the date of the procedure was on (b)(6) 2023.The procedure was an upper endoscopy.The date of the patient symptoms were on (b)(6) 2023.The patient symptoms were flank pain, pain, night sweats and nausea.The treatment used was ceftriaxone, ceftazidime-avibactam meropenem and colistin.The infection verification was a culture/pcr-polymerase chain reaction.The positive culture was received on (b)(6) 2023.The organism identified was klebsiella pneumoniae, ndm+.The specimen source was in the urine and blood.The patient had no significant past medical history, admitted with sepsis due to pyelonephritis.The patient is a 64 year old white male with a bmi or 26.9.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide correction to the initial with information inadvertently left out b3 and to provide additional information.Additional information received: (b)(6) 2024 olympus endoscopy support specialist (ess) followed up with the facility and confirmed that reprocessing steps by the user had no deviation for the instructions for use, post the last in-service correction that was performed on (b)(6) 2023.Although it was recommended to send in the subject device for cultures, the user did not agree to culture test and the subject device was not returned for inspection.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, olympus was not able to judge relation between the subject device and the event from the following investigation results.Additionally, it is likely the reported event occurred because reprocessing was insufficient due to deviation from the instruction for use.However, the root cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 18789397
• MDR Text Key: 336394809
• Report Number: 9610595-2024-04072
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• 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
• Report Date: 05/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 05/28/2024
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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: 64 YR
• Patient Sex: Male
• Patient Race: White