MAUDE Adverse Event Report: OLYMPUS WINTER IBE GMBH OLYMPUS; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number WA02946A

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problems Edema (1820); Foreign Body In Patient (2687)

Event Date 01/02/2018

Event Type  malfunction  

Event Description

We had just started the procedure when the doctor asked for a second guidewire.After receiving the wire, he placed the wire then ran the semi-rigid ureteroscope over the wire.Once the scope was in place, he tried to remove the wire through the scope and at that point had a little difficulty in doing so.Once he was able to remove the wire he noticed that the wire had some places where the coating was chipped away.He looked around using the scope to verify that none had chipped off inside the patient but there was a lot of edema so he placed a stent.

• Brand Name: OLYMPUS
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS WINTER IBE GMBH; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 7221086
• MDR Text Key: 98313113
• Report Number: 7221086
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: WA02946A
• Device Catalogue Number: WA02946A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR