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  

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.This medwatch is related to patient identifier: (b)(6).

• 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
• MDR Report Key: 18866163
• MDR Text Key: 337222280
• Report Number: 2429304-2024-00194
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/07/2024,03/08/2024

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?: Yes
• Distributor Facility Aware Date: 02/07/2024
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/07/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYSTO-NEPHRO VIDEOSCOPE CYF-V2
• Patient Outcome(s): Required Intervention
• Patient Sex: Male