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

Model Number URF-P6R

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No additional information of the event is available yet.Date of event is unknown, nor is it known at what stage the event took place.The device has been returned for evaluation.On inspection it was noted to have a leak on the c cover and a broken bending section.We are not able to determine the exact cause of the broken bending section.The instructions for use warn, "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable 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".

Event Description

As reported for this event, it was observed that the device deflecting tip mechanism was broken.The device bending section was broken with metal protruding.Patient involvement is not reported.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h4, h6, and h10.The device history review confirmed that device manufacture conformed to specifications; the design of the bending tube is such that it precludes injury to patient body.The cause of the issue of the broken bending section is likely to be user handling.Bending tube breakage is preventable by handling in accordance with instructions for use (ifu).The product¿s ifu includes statements on bending tube breakage as follows: important information please read before use : 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.Bending tube breakage is detectable by handling in accordance with ifu.The device ifu includes statements on inspection as follows: inspection of the endoscope : inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Also, the insulation of the distal end was non-olympus product.There is a deviation from instructions ifu for repair work for the device.The device ifu includes statements on repair work as follows: repair performed by persons who are not qualified by olympus could cause patient or user injury and/or equipment damage.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9937157
• MDR Text Key: 196148412
• Report Number: 8010047-2020-02056
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1