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 Sepsis (2067); Drug Resistant Bacterial Infection (4553)

Event Date 01/26/2023

Event Type  Death  

Event Description

The customer initially reported that the evis exera iii gastrointestinal videoscope tested positive for bacteria and is requesting all channels to be replaced and that four (4) patients tested positive for escherichia coli (e.Coli) extended spectrum beta-lactamase (esbl).It was reported that the customer was using the gastroscope for colonoscopy.Patient 1 of 4 had an endoscopy procedure with the subject device on (b)(6) 2023.The patient's urine sample was cultured on (b)(6) 2023 and tested positive for microbial contamination.On (b)(6) 2023, the patient's blood and urine were cultured and also tested positive for microbial contamination.The patient had urinary tract infection followed by sepsis, with a working diagnosis of urosepsis, and was treated with ceftriaxone on (b)(6)2023, switched first to tobramycin on (b)(6) 2023 and then to meropenem from (b)(6) 2023.The customer reported there was no hospitalization.The patient was discharged to a nursing home (b)(6) 2023 where he had recovered from the infection, but delirium continued.It is unknown if the patient had delirium prior to the procedure.The patient died a few days later and the facility believes it was a result of general decline.The facility reported the patient had multiple cultures of his throat, rectum and urine in (b)(6)2022 and the results were negative.The customer reported there was no epidemiological relationship with the other three (3) patients and the only connection was the same endoscope.The customer stated a contact investigation was started for gif-hq190 with serial number (b)(6) due to patient 1's urine and blood testing positive for e.Coli esbl, and which emerged from the urine and blood cultures approximately one and a half weeks following the procedure with the subject device on (b)(6) 2023.The customer reported the dna profile of the bacteria looked very much ("very close relationship") to 3 other patients' dna profiles from (b)(6) 2022.Epidemiological research showed that the only common factor in these 4 patients is this endoscope.After consulting with physicians, the facility sent culture kits to ten (10) patients who had procedures with the same subject device around the date of (b)(6) 2023 to find out whether more patients are positive.The facility determined to test eight (8) patients in the two weeks prior to (b)(6) 2023 and two (2) patients after (b)(6) 2023.The results are pending.The endoscope was used twice after patient 1 and the patients are being tested.After being used twice and identifying a link between the four patients, the subject device was quarantined.In (b)(6) 2023, the subject device was viewed with a "spyscope", and the last part of the canal was identified as damaged.The canal was cultured with negative findings.The customer clarified that there was no culture result but that it concerns a patient with an invasive infection with an e.Coli esbl (st131, ctx-m-27 with a co-resistance to ciprofloxacin and co-trimoxazole).The facility is taking samples of every patient after every treatment in the hospital as well as do dna tests of all samples; hence, this data was found.Additional information is being requested on the details surrounding patient 1's death as well as the status and any treatment given for patients 2, 3, and 4.Case with patient identifier (b)(6) reports patient 1/4.Case with patient identifier (b)(6) reports patient 2/4.Case with patient identifier (b)(6) reports patient 3/4.Case with patient identifier (b)(6) reports patient 4/4.This medwatch is for patient identifier (b)(6).

Manufacturer Narrative

The suspect device has not been returned to olympus.The customer provided the cleaning, disinfection, and sterilization process.Pre-cleaning was performed immediately after the patient procedure.Water was aspirated through the instrument / suction channel with a suction pump.The device passed the leak test.The instrument / suction channel, suction cylinder, and instrument channel port were brushed.The automated endoscopic reprocessor (aer) used was wassenburg.There were no defects noted on the aer.The aer detergent was mediclean forte and the aer disinfectant was neodisher speto.All the channels were connected with tubes when the endoscope was setting up into the aer.It was unknown if the concentration of and expiration date of the disinfectant was controlled.The water quality of the rinse water was controlled.The water filter was replaced periodically in accordance with the instructions for use (ifu).The device was dried using a drying cabinet or was used wet on a patient within four hours.It was stored in a drying cabinet.The device was sent out for additional microbiological testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured with negative results.In addition, there was damage at the distal end of the suction channel, which was also cultured and was negative.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and evaluation.The device was returned to olympus for inspection, and no abnormalities were found that could have led to the positive culture.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.The root cause of the phenomenon could not be identified.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.¿ "intended use: the evis exera iii gastrointestinal videoscope gif-h190, gif-hq190, gif-1th190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum)." in addition, the following non-reportable malfunctions were found during the device evaluation: plastic distal end cover insulation under threshold, charge-coupled device cover lens scratched, damaged plastic distal end cover, bending section cover glue cracked, connecting tube scratched, painting peel off of suction cylinder nut, switch box unit scratched, and universal coed buckles with scratches.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: 17008051
• MDR Text Key: 315995387
• Report Number: 9610595-2023-08078
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2020
• 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 Outcome(s): Required Intervention; Death