MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; CYSTOURETHROSCOPE

Model Number 8626431

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/21/2021

Event Type  malfunction  

Event Description

Physician was doing a cystoscopy on the patient with a richard wolf gmbh panoview cystoscope.Physician noticed a foreign body inside the bladder of the patient.Medical staff checked and the scope was missing its lens cover.The surgeon retrieved the lens cover by using a grasper.No harm to the patient.

• Brand Name: PANOVIEW
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; 353 corporate woods pkwy.; vernon hills IL 60061
• MDR Report Key: 12589862
• MDR Text Key: 275167901
• Report Number: 12589862
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2021

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: Health Professional
• Device Model Number: 8626431
• Device Catalogue Number: 8626.431
• 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: 09/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1