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

Model Number URF-P6R

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The scope was not returned to olympus for evaluation.Olympus learned that the user facility uses a non-olympus third party for service and repair.The reported device has been refurbished at least four times by the third party service provider.A review of the instrument history was performed and found that the scope was purchased by the user facility on (b)(6) 2013 and has never been returned to olympus for service since then.In addition, olympus requested the user facility to return both the scope and the detached distal end of the scope; however, the user facility has denied the request stating that this matter will no longer be discussed with olympus and will solely be discussed with the non-olympus third party entity.The cause of the reported event could not be conclusively determined; however, improper maintenance and operator¿s technique could not be ruled out as contributory factors to the reported event.The instruction manual for use states, ¿this instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result.Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus¿ own authorized service personnel is excluded from olympus¿ limited warranty and is not warranted by olympus in any manner.¿.

Event Description

Olympus was informed that during a laser ureteroscopy procedure, the distal end of the scope (approximately 5mm to 1cm) became stuck inside the patient¿s ureter when the physician was attempting to withdraw the scope after breaking a large stone inside the patient¿s ureter using a holmium laser.The distal end of the scope was in a straight position and not in a retroflexed state.It was reported that the attending physician received assistance from other urologists in the facility in an attempt to remove the scope, but with no result.The physician then decided to cut a portion of the distal end, leaving a portion of the scope inside the patient, waiting for the patient¿s ureter to become dilated and perform the surgical removal of the scope from the patient.The piece of the scope¿s distal end was successfully removed from the patient on (b)(6) 2017.A follow up procedure on (b)(6) 2017 will insert a stent in the patient¿s kidney and bladder.It was also reported that a team is in place for a robotic laparoscopy to reattach the patient¿s ureter to his kidney in the event that the stent procedure is not successful.

Manufacturer Narrative

This supplemental report is being submitted to provide the medwatch report number received from fda.On january 5, 2018, olympus received a medwatch report (mw5074007) from fda in regards to this reported event.All information provided in the medwatch was previously reported by olympus.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7153116
• MDR Text Key: 96003352
• Report Number: 2951238-2017-00790
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Device Catalogue Number: URF-P6R
• Device Lot Number: N/A
• Other Device ID Number: 04953170340833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention