MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION URETERO-RENOVIDEOSCOPE; URETEROSCOPE

Model Number URF-V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 05/30/2014

Event Type  Injury  

Event Description

Olympus was informed that during an unspecified procedure, the pt was cut with a laser.Olympus followed up with the user facility and was informed that during the procedure the ureteroscope was cut with a laser and upon withdrawing the ureteroscope, the pt was injured.There was moderate bleeding noted.It is unk how the bleeding was controlled.When the device was completely withdrawn, it was observed that there was abraded steel on the distal tip where the laser had cut the ureteroscope.

Manufacturer Narrative

The ureteroscope referenced in this report was returned to olympus for evaluation.The evaluation confirmed that the bending section (distal sheath) had physical damage at the distal end.The bending section cover glue was found cracked.The forceps and brush passages were restricted due to a smashed and dental insertion tube.It ws noted that there was no image when tested.The bending section mesh wires were exposed and sticking out, and the ris of the device were torn and broken.The device was refurbished and returned to the user facility.

• Brand Name: URETERO-RENOVIDEOSCOPE
• Type of Device: URETEROSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi; tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4134905
• MDR Text Key: 4944772
• Report Number: 2951238-2014-00435
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/08/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: URF-V
• Device Catalogue Number: URF-V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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