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

Model Number URF-V2R

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.During evaluation, it was determined the endoscope had a broken bending section skeleton that punctured the cover (or distal sheath) attributing to a leak due to physical damage.The endoscope has been reassembled with a new insertion tube unit.In addition, the light guide connector, the tension adjustment on control knobs, the body control unit, the light guide tube, the suction cylinder and tube, the air/water cylinder and tube, the light guide cover glass, and switch and button were repaired and/or replacement.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, there was a broken distal tip found on the uretero-reno videoscope during maintenance after an unknown procedure.There were no reports of patient harm with this event.During the inspection of the returned device, it was found to have cut at the bending section cover.The medical device report (mdr) is being submitted to capture the reportable malfunction of the cut at the bending section cover found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 following likely caused the event.The user manipulated device which added excessive force to the bending section, the bending tube was broken.The root cause of why the device was not handled according to the device ifu could not be determined.The following is included in the ifu and may have helped prevent the event: "perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk." "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." "do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc." "do not insert the insertion tube with excessive force and twist." "do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged." olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14317730
• MDR Text Key: 299780834
• Report Number: 8010047-2022-07796
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343612
• UDI-Public: 04953170343612
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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