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).

• 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

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Date Manufacturer Received: 01/12/2023
• 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 Treatment Data

Date Received: 12/16/2022 Patient Sequence Number: 1