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

Model Number URF-P6

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

There is no additional information for this event available yet.Event date is unknown.Supplemental report(s) will be filed as the information becomes available.The device has been returned and a device evaluation completed.The device has a break with bending section with support pin lifted and protruding through a-rubber.There is leaking from the distal end, a-rubber and instrument channel.A-rubber has a hole and the glue is peeling.The image has 10 plus breakages.This device does have non- olympus repairs to a-rubber/glue, the insertion tube and the u/d plate.Cause for the reported issue is user mishandling during transit of device after use in a procedure.

Event Description

As reported for this event, during transportation due to mishandling after the procedure, there was a tear in the distal tip with some of the internal structure is exposed.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Event date is provided.The occupation position of the initial reporter is quality control coordinator.Additional information about the event is that during transportation the device had a heavier tray placed on top of the distal tip in the case cart.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device was shipped in accordance with specifications.Safety measures are provided to prevent the protrusion of metal from the a-rubber.The root cause determined from the investigation is mishandling by the user by a heavy tray placed on top of the distal tip which added excessive stress to bending tube.As a result, bending tube was broken and support pin protruded breaking the a-rubber.Chain of occurrence is as follows: the user transported the scope after procedure, while transporting the heavy tray was placed on distal end.Excessive stress was added to bending tube, which caused bending tube breakage and support pin raised.The support pin protruded out of a-rubber.User mishandling caused damage on the device while transporting after procedure.Confirmed deviation of the instructions for use (ifu) by the user.The device ifu for handling are as follows: important information ¿ please read before use : 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.The device ifu for a-rubber breakage are as follows.This issue is detectable by inspection prior to use in per the ifu.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.The device ifu for the bending tube breakage are as follows.Bending tube breakage is preventable by handling in accordance with ifu.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.The device ifu for repair work as follows.We confirmed deviation per ifu for repairs by third party for a-rubber, a-rubber glue and connecting tube.Troubleshooting guide: as 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9959927
• MDR Text Key: 208988534
• Report Number: 8010047-2020-02202
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• 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