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

Model Number GIF-1100

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 11/03/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.It was reported that the device was immediately placed in quarantine on (b)(6) 2022.The exact cause of the reported event cannot be conclusively determined.The investigation is still ongoing, and a supplemental report will be submitted once the investigation completed and if new information becomes available later.

Event Description

Olympus was informed about a hygiene issue and a multi-resistant germ found in an unidentified olympus gastroscope.The clinic has recently converted the entire endoscope park to olympus.Reprocessing is done in gettinge-rdg-e, which was newly purchased last year.Currently, the clinic reportedly had an outbreak of four multi-resistant gram negative (mrgn) klebsiella pneumoniae with oxa 181 (emerging carbapenem-hydrolyzing oxacillinase).The customer had detected 80 cfu/10ml of k.Pneumoniae in the water channel of a new gastroscope, as part of their endoscope check.The carbapenemase rapid test was positive for oxa 48.However, it may still turn out to be oxa 181 in the nrz (nitrate reductase).The customer further reported that they had this several times in the outbreak and this gastroscope was used on a patient who was part of the outbreak.According to the clinic, there are frequent error messages in the rdg-e in which the gastroscope was prepared.It was further reported that there were two patients that were treated with this pathogen in the intensive care unit and were examined with the subject device a few days before the lagus sampling.This mdr is being submitted to account for the second patient.The first patient¿s report was reported under complaint number (b)(4).

Event Description

Update: additional information provided by the physician: clarification/sequence of events: one patient who was infected with the hospital pathogen was examined with the olympus endoscope.After that seven additional patients were examined with the endoscope until the device was sampled by the lagus and the germs were detected on the device/the device was taken in quarantine.The device was then sent to olympus for hmi/repair and no germs were found during hmi.Between the patients the reprocessing was of course carried out completely in each case none of the seven examined patients so far have an infection that could be detected with the same microorganism.Nevertheless, the patients were "marked" as potentially being at risk and will be examined again - if applicable.In summary: there is currently only a risk potential for the patients and no proven infection has occurred due to the contamination of the olympus endoscope.

Manufacturer Narrative

This report is being updated to report additional information provided by the customer.New information is reported in b5.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the physical evaluation of the device.The following sections were updated: d8, d9, h2, h3, h4, h6, and h10.The subject device was returned to olympus for evaluation.Based on the evaluation performed, the device passed all functional tests and inspections.No problem found with the device.

Manufacturer Narrative

This supplemental report is being submitted to correct the aware date of the initial mdr from november 8, 2022 to december 6, 2022.Olympus learned about the incident involving a second patient on december 6, 2022.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.As previously reported, the device was evaluated where 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.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.Furthermore, it was confirmed that the user did not make any obvious deviations from the reprocessing steps in the ifu.The following is included in the device ifu: ¿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: 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: 15999768
• MDR Text Key: 305682811
• Report Number: 9610595-2022-05611
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/08/2023

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-1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 12/19/2022; 01/17/2023; 01/12/2023; 04/14/2023
• Supplement Dates FDA Received: 01/06/2023; 01/20/2023; 02/10/2023; 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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
• Patient Sex: Unknown