MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V2

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.This event has been reported by the importer on mdr# (b)(4).

Event Description

Olympus received medwatch 5096215.It was reported that during the beginning of a cystoscopy with bilateral retrograde pyelograms, bilateral ureteroscopy, laser lithotripsy and stent, while the physician was using the ureteroscope, the laser did not fire correctly.Subsequently, the physician switched to another fiber and when lasering the ureter, a piece of the fiber broke off into the patient.Per the physician, this was possibly due to the ureteroscope.Retrieval was attempted to no avail as the fragment fell off the basket during removal.The physician was unable to find the fragment.It was noted the same ureteroscope was used to complete the procedure which was delayed by minutes[sic].Per the clinician, patient follow-up appointments indicate no negative outcomes from the procedure.No further attempts to remove the fragment are required.

Manufacturer Narrative

The legal manufacturer reviewed the contents of this complaint.As the results of the dhr review, it was confirmed that the product was shipped conforming to the specifications.The legal manufacturer reported that the root cause could not be determined.The legal manufacturer reported that the most probably cause for the reported event is the following: the event was due to the laser probe breakage.The legal manufacturer reported that it is presumed the following factors attributed to the reported event, based on the ifu and similar complaint investigations.· the laser probe was used with the broken scope, which led to the laser shot penetrating at the location of the probe being massively bent.· the user inserted the laser probe while bending tube was angulated or massively stressed.· angulation was manipulated while the laser probe was inserted in biopsy channel.The legal manufacturer refers to the ifu entries below in an effort to mitigate product damage.Important information ¿ please read before use : warning : never use the endoscope on a patient if an irregularity is observed.Damage or an irregularity in the endoscope may compromise patient or user safety and may result in more severe equipment damage.Particularly, if an examination is continued using an endoscope with its insertion section damaged, the following event may occur: · components of an endoscope fall off inside the patient body.· mucosal damage, bleeding, perforation caused by an exposed metal part from the insertion section.· an endoscope is not smoothly withdrawn from the patient.· an endotherapy accessory is damaged (including components of the accessory falling off inside the patient body, unexpected irradiation from a damaged laser probe).·4.3 using endotherapy accessories : warning : if an endotherapy accessory is used with a damaged endoscope, the accessory may be damaged and the damage may result in the accessory¿s components falling off inside the patient, or patient injury (including unexpected irradiation from a damaged laser probe).·4.4 using the laser system : caution : do not insert the laser probe into the instrument channel while applying an excessive force or bending the bending section.The instrument channel and/or laser probe may be damaged.Do not bend the bending section with excessive force while the laser probe is inserted into the instrument channel.The laser probe may be damaged.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10619895
• MDR Text Key: 209598006
• Report Number: 8010047-2020-07151
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 200 MICRON LASER FIBER; 365 MICRON LASER FIBER; 200 MICRON LASER FIBER; 365 MICRON LASER FIBER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 103