MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES CYSTOFIBERSCOPE; CYSTONEPHROFIBERSCOPE

Model Number CYF-4

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/24/2023

Event Type  Injury  

Event Description

It was reported, a piece of the scope broke off inside the patient during a fulguration procedure on (b)(6) 2023.The patient came back for a cystoscopy on (b)(6) 2024 and the part of the scope that fell inside the patient on (b)(6) 2023 was discovered at this time and was successfully removed.Additional procedural details were requested but not provided.

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-00211.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the subject device was not returned, and a specific root cause of the reported event could not be identified.The event can be prevented by following the instructions for use which state: chapter 3 preparation and inspection, warning: "before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use this instrument and see chapter 9, ¿troubleshooting¿.If the irregularity is still suspected after consulting chapter 9, contact olympus.Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage." chapter 9 troubleshooting "the endoscope is visibly damaged, does not function as expected or is found to have other irregularities during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope.Contact olympus." "problems that appear to be malfunctions may be correctable by referring to, ¿troubleshooting guide¿.Should you fail to correct the problem even after taking the described remedial action, stop using the endoscope and send it to olympus for repair." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to the previous submissions.A correction has been made to e2, e3, and g2 to provide information that was inadvertently not included in the previous submissions.Also, h6 codes "3331" and "4111" were submitted in the previous submission, and do not apply to this complaint.Therefore, both codes have been removed.Furthermore, the device history record (dhr) 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.

• Brand Name: OES CYSTOFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 18990186
• MDR Text Key: 338773244
• Report Number: 9610595-2024-06537
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K843084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2024
• 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