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

Model Number MAJ-891

Device Problems Microbial Contamination of Device (2303); Failure to Clean Adequately (4048)

Patient Problem Bacterial Infection (1735)

Event Date 08/08/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "pulling the plug on a pseudomonas outbreak: ancillary equipment as vectors of infection".Fifteen patients were infected with pseudomonas aeruginosa.All of the pseudomonas aeruginosa isolates from clinical samples matched strains of pseudomonas aeruginosa isolated from the subject device.Out of 15 cases, 12 cases were already reported in august 2020.(b)(6).The following three patients are for the three infection cases found after august 2020.Patient 3- (b)(6): the patient had intercurrent p.Aeruginosa infection, and was recognized as related to the outbreak 18 months after their cystoscopy requiring medical interventions that was managed in the community.Patient 6- (b)(6): the patient presented to the hospital with a clinical diagnosis of urosepsis three days after their cystoscopy.The urine sample collected on admission was not processed as it was unlabeled.A repeat sample was collected after the patient had received several days of antibiotic.The sample showed an elevated white cell count but did not grow any bacteria.This patient was confirmed as part of the outbreak 8 months after their procedure, when the further urine sample grew p.Aeruginosa.Hospital admission was indicated for a unrelated indication and incidental treatment of a urinary tract infection.Patient 12- (b)(6): the patient was confirmed as part of the outbreak within 2 weeks of their cystoscopy and a hospital admission with intravenous antibiotics.This medwatch represents patient 3- (b)(6).

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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 and/or 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, the relationship between the device and the adverse event cannot be confirmed.Therefore, the root cause cannot be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: "failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety." this supplemental report includes a correction to e1 form the initial medwatch.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: 18278918
• MDR Text Key: 329890219
• Report Number: 9610595-2023-18939
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/21/2024
• 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
• Patient Outcome(s): Required Intervention; Other