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

Model Number URF-V2

Device Problem Break (1069)

Patient Problems Laceration(s) (1946); Tissue Damage (2104)

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for this event.Olympus followed up with the user facility to obtain additional information regarding the reported event via telephone and in writing but with no result.The cause of the reported event cannot be determined.A review of the instrument history revealed that the scope was previously returned to olympus for service on may 4, 2016.An evaluation was performed at that time and found the a-rubber and the bending section of the device critically damaged.The inspection also noted a leak that resulted in fluid invasion in the control body of the scope.The scope was repaired and returned to the user facility.

Event Description

Olympus was informed that during a right ureteroscopy with laser and basket stone retrieval procedure, while withdrawing the scope, the bending section broke and tore the patient's ureter.It was reported that the surgeon implanted a stent in the patient that will remain for three weeks.It is unknown if the intended procedure was completed.The patient will continue to be monitored.On (b)(6) 2016, olympus received a mandatory medwatch ((b)(4)) which provided additional information regarding the type of procedure and the patient information for the previously reported event.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 5995128
• MDR Text Key: 56335047
• Report Number: 2951238-2016-00778
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Device Catalogue Number: URF-V2
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• 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): Required Intervention
• Patient Age: 41 YR