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 Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This medwatch is related to mfr report number 9610595 - 2024 - 00012.

Event Description

It was reported, there was leakage and pseudomonas contamination with the visera cysto-nephro videoscope.The microbiology test reported a positive sample.Patients with infection began to arrive, the amount of patients or type of infection was not specified.It was identified that these patients had recently undergone cystoscopy procedures, therefore the cystoscopes and washing machines were tested, and one of the scopes tested positive.Around 20 days prior, customer had performed culture tests in all the devices and the results were correct.An assessment was performed by an olympus field service engineer and it was found that the use of the irrigation plug was not reprocessed correctly.The customer explained they usually disassemble and plunge in the same disinfectant solution they use with the cystoscopes.They do not brush, they only rinse before introducing in the disinfectant solution.

Manufacturer Narrative

A cleaning, disinfection and sterilization checklist was provided in related complaint (b)(4).The devices have been re-processed and stored as they always are.Pre-cleaning was performed immediately after the patient procedure.Water was not aspirated through the instrument/suction channel with a suction pump.The instrument/suction channel was brushed.The device was not rinsed before manual disinfection.All channels were flushed with and immersed into the disinfectant.The concentration and expiration date of disinfectant were controlled.The aer/ewd used was minietd2.There were no defects on aer/ewd.All channels were connected with tubes when the endoscope was setting up into the aer/ewd.The concentration and expiration date of disinfectant were controlled.The water quality of the rinse water was controlled.After processing, the device was not dried.Olympus provided the following result of the culture test, performed at the third-party labs: sampling (prior to cleaning, disinfection and sterilization of cyf-va2 by olympus): sampling date: (b)(6) 2024.Sampling from: sampling solution instrument/biopsy/suction channel cfu: >20.Bacterial identification: pseudomonas stutzeri.Sampling (prior to cleaning, disinfection and sterilization of cyf-va2 by olympus): sampling date: (b)(6) 2024.Sampling from: sampling of swabbing distal end unit.Cfu: 0 cfu.Bacterial identification: no detection.Sampling (after cleaning, disinfection and sterilization of cyf-va2 by olympus): sampling date: (b)(6) 2024.Sampling from: sampling solution instrument/biopsy/suction channel and sampling of swabbing distal end unit.Cfu: 0 cfu.Bacterial identification: no detection.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot 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, a relationship between the subject device and the reported adverse event could not be identified.However, after reviewing the user¿s reprocessing steps, it was determined that the user deviated from the instructions for use (ifu) manual.Although, the root cause could not be determined.The event can be detected/prevented by following the ifu 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: 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: 18937271
• MDR Text Key: 338075515
• Report Number: 9610595-2024-05853
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/21/2024; 04/26/2024
• Supplement Dates FDA Received: 03/21/2024; 04/29/2024
• 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: VISERA CYSTO-NEPHRO VIDEOSCOPE (CYF-VA2).; VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-VA2 / W040466.
• Patient Outcome(s): Other