MAUDE Adverse Event Report: PUNSEN URETERORENOSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

During a flexible ureterorenoscopy procedure performed for kidney stones by dr.(b)(6) at hospital (b)(6) on (b)(6) 2020, "the client was using a punsen ureterorenoscopy (non-boston scientific product) and it wasn't working properly.To prove it, the client opened two lightrail fibers [boston scientific products] that were in perfect conditions.This complain isn't due to the fibers, but due to a punsen ureterorenoscope that wasn't working and to prove it the surgeon opened two lightrail fibers and only used one".This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: URETERORENOSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): PUNSEN
• MDR Report Key: 17530187
• MDR Text Key: 321130598
• Report Number: MW5137107
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2020

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1