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

Model Number URF-V

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and the event of too stiff could not be duplicated.Additionally, pinholes and leaking were found at the insertion tube.The cause cannot be determined at this time.If additional information becomes available at a later time, this report will be supplemented.This event has been reported by the importer on mdr# 2951238-2020-00481.

Event Description

It was reported that during a procedure, the device was too stiff and caused trauma.Although requested, additional information has not been provided.

Manufacturer Narrative

This report is being supplemented to provide additional information (h6, h10) regarding the reported event.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The definitive root cause of the reported event could not be established as when evealuated we were unable to duplicate the reported problem.The instruction for use state: "if significant resistance is felt and insertion becomes difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting endotherapy accessories with excessive force may damage the endoscope and/or the accessory.Confirm that the tip of the endotherapy accessory is closed or retracted into its sheath and then slowly insert it into the forceps port.Do not open or extend the tip of the endotherapy accessory from its sheath while inserting it into the channel.The endoscope and/or the accessory may be damaged.Use endotherapy accessories with the same color code (ø 1.2 mm channel).Otherwise, the endoscope and/or the endotherapy accessory may be damaged.Hold the endotherapy accessory and insert it straight into the forceps port using slow, short strokes.Otherwise, the sheath of the endotherapy accessory could bend or break.".

Manufacturer Narrative

This supplemental report is submitted to provide additional information.

• 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: 10314092
• MDR Text Key: 203297094
• Report Number: 8010047-2020-04755
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other