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

Model Number URF-P6R

Device Problem Break (1069)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

The device was returned by the customer for the evaluation and repair of the issue of broken lens observed during reprocessing.There is no patient involvement and no harm reported to any patient.Upon evaluation of the device, it was observed that the distal end rubber coating (a-rubber) has a hole and is folded with the bending section broken skeleton pierced through and protruding.This medwatch is being submitted for the bending section broken skeleton pierced through and protruding from the a-rubber observed during device estimation.

Manufacturer Narrative

Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that the distal end rubber coating (a-rubber) has a hole and is folded with the bending section broken skeleton pierced through and protruding.The other observations for the device are: distal end rubber coating (a-rubber) still leaking after being taped; distal end plastic c-body has dents and scratches; objective lens has deep scratches; forceps passage and brush passage have restriction due to deformation; image is intact, but there are multiple broken fibers; and angulation is below the standard.The user¿s complaint of broken lens was confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Manufacturer Narrative

The aware date entered on the initial medwatch report (medwatch number 84252/mfr report number 8010047 2022 06685) was 04-march-2022.The correct aware date is 28-february-2022.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.The subject device was refurbished on 22-november-2021.A definitive root cause for the broken bending tube was not established.The reported event may have occurred due to inappropriate user handling of the device.The occurrence of the reported event can be reduced by adhering to the following instructions from the instructions for use: "warnings and cautions: warning: 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.Inspection of the endoscope: inspect the bending section for bends, twist, or other irregularities while the bending section remains straight.Inspect the bending section for abnormal bending shape, or other irregularities.Precautions: caution: 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." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

The following statement was included in the first follow up report with mfr# 8010047 2022 06685."the aware date entered on the initial medwatch report (medwatch number 84252/mfr report number 8010047 2022 06685) was 04-march-2022.The correct aware date is 28-february-2022." premarket identification above is a typo.The corrected field in the first follow up report was(date received by manufacturer).This second follow up report is being submitted to capture this correction.

• 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: 14160681
• MDR Text Key: 298961744
• Report Number: 8010047-2022-06685
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2021
• 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