MAUDE Adverse Event Report: OLYMPUS AMERICA, INC URETERO-RENO FIBERSCOPE

Model Number URF-P7R

Device Problems Product Quality Problem (1506); Protective Measures Problem (3015)

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

Event Date 02/03/2023

Event Type  Injury  

Event Description

The customer reported to olympus that the uretero-reno fiberscope had laser fibers left in it from a previous case.The current laser fiber was inserted and reportedly pushed out the old laser fiber pieces into the patient's ureter during an unspecified therapeutic procedure.The procedure was prolonged by a couple of minutes with the patient under sedation since the old fiber pieces had to be retrieved with a grasper and the scope had to be replaced.The procedure was completed using a similar device.The scope was sent back to be reprocessed and then an error message occurred.There was no harm, injury, or infection reported due to the event.This is related to patient identifier number (b)(6), which is for the laser fibers.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 16483149
• MDR Text Key: 310685244
• Report Number: 2429304-2023-00031
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403835
• UDI-Public: 04953170403835
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2023,03/03/2023

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-P7R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASER FIBERS WITH UNKNOWN SERIAL OR LOT NUMBER.
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 108 KG