MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V3

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.Additional information found during inspection and testing were; biopsy channel and angulation rubber were leaking, light guide bundle had more than 15% of broken fibres; switches were faulty; image had uneven illumination; angle lever had rotation, play, problem; bending angle did not meet specification; bending return angle was not within specification; lock engagement lever was not engaging correctly; distal end adhesive was detached, scratched and chipped; control unit was corroded due to water leakage.Water tightness was lost due channel tube damage and a pinhole in the distal sheath.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the scope on the uretero-reno videoscope did not move up or down.Inspection and testing of the returned device found bending section cannot be controlled due to corrosion on the angle mechanism.It was reported that the scope was laying on top of the patient and not being used, and then it fell onto the floor.No further information was provided.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the bending section couldn¿t be controlled as the water tightness of channel tube and/or bending section cover was lost during user handling of the device, as a result there was water invasion to the control section.The root cause of this event was unable to be identified.The event can be detected by following the instructions for use which state: ¿·inspection of the endoscope-inspection for smooth operation-operate the up/down angulation control lever slowly in each direction until it stops.Confirm that the bending section angulates smoothly and correctly and confirm that maximum angulation can be achieved.·warnings and cautions: operation-if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient as described in section 5.3, ¿withdrawal of the endoscope with an irregularity¿.·continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation.·warnings and cautions: operation-if an abnormal endoscopic image appears or an abnormal function occurs but quickly corrects itself, the endoscope may have malfunctioned.In this case, stop using the endoscope because the irregularity can occur again and the endoscope may not return to its normal condition.Stop the examination immediately and slowly withdraw the endoscope while viewing the endoscopic image.Otherwise, patient injury, bleeding, and/or perforation can result.¿ the event can be prevented by following the instructions for use which state: ¿·do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.·never perform angulation control forcibly or abruptly.Never forcefully pull, twist, or rotate the angulated bending section.Patient injury, bleeding, and/or perforation may result.It may also become impossible to straighten the bending section during an examination.¿ olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 15834427
• MDR Text Key: 304355545
• Report Number: 9610595-2022-04356
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• 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