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  

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

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.A cleaning, disinfection and sterilization checklist was provided.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 (b)(6) by olympus): sampling date: (b)(6) 2024.Sampling from: sampling solution instrument/biopsy/suction channel cfu: (b)(4) bacterial identification: (b)(4).Sampling (prior to cleaning, disinfection and sterilization of (b)(6) by olympus): sampling date: (b)(6) 2024 sampling from: sampling of swabbing distal end unit cfu: (b)(4) bacterial identification: no detection.Sampling (after cleaning, disinfection and sterilization of (b)(6) by olympus): sampling date: (b)(6) 2024.Sampling from: sampling solution instrument/biopsy/suction channel and sampling of swabbing distal end unit.Cfu: (b)(4) bacterial identification: no detection.This medwatch is related to mfr report numbers 9610595 - 2024 - 00012, 9610595 - 2024 - 05853, and 9610595 - 2024 - 00480.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The dhr 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.The case is not due to design.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to the user deviating from the reprocessing steps recommended by olympus, and a difference in recognition on handling or reprocessing steps between olympus¿ recommendation and the user facility.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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19009006
• MDR Text Key: 338982444
• Report Number: 9610595-2024-06726
• 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
• Report Date: 03/29/2024

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/30/2024
• 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)
• Patient Outcome(s): Other