MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

Device Problem Failure to Clean Adequately (4048)

Patient Problem Urinary Tract Infection (2120)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus for evaluation.The investigation is ongoing, and this report will be supplemented when new and relevant information becomes available.This medwatch is related to patient identifier: ((b)(6)).This report was submitted by the importer under the importer's report number: 2429304-2024-00194.

Event Description

It was reported, a urinary tract infection (uti) with pseudomonas occurred after cystoscopy in which the patient received levaquin treatment.The olympus endoscopy support specialist (ess) was on-site for observations of cleaning with facility staff and identified the customer was not disassembling the forceps/irrigation plug during reprocessing.The ess completed a reprocessing in-service to correct deviations and provided customer with scope cleaning directions.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide additional information received through follow-up (b5 and expert reviews).The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the subject device was not returned, and the subject device was not cultured, therefore; olympus was not able to judge the relation between the subject device and the event from the following investigation results.Additionally, it is likely the reported event occurred due to a misunderstanding of device handling and reprocessing steps between the user and olympus¿s recommendation.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.¿.Additional information based on olympus expert reviews: it is very possible for biofilm to form in between the segments of the maj-891, as this piece has been linked to outbreaks.It is recommended to obtain microbiological samples of the involved endoscopes and the involved maj-891 (and the loose parts that need to be brushed).Olympus will continue to monitor field performance for this device.

Event Description

It was reported by the customer that after the olympus in-service training, there have been no further related issues at the facility.The forceps/irrigation plugs (maj-891) used at the facility are disassembled and cleaned correctly.The patients involved in the events are reportedly ¿fine after treatment,¿ and currently in ¿good¿ condition.It was confirmed that the patients did not develop bacteremia or sepsis and did not require admission to the icu.Furthermore, the facility reported receiving reprocessing training when the flexible cystoscope (cyf-v2) was introduced for use.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• 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: 18860311
• MDR Text Key: 337185241
• Report Number: 9610595-2024-04964
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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: MAJ-891
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CYSTO-NEPHRO VIDEOSCOPE CYF-V2
• Patient Outcome(s): Required Intervention
• Patient Sex: Male