MAUDE Adverse Event Report: CYSTOSCOPE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Date 06/05/2023

Event Type  malfunction  

Event Description

A reporter called to report that a cystoscope broke while the doctor is trying to remove the stent placed in her ureter for kidney stone removal.She said the procedure was on (b)(6), and she went back in about a week to have the stent taken out.She said she was under the impression they would give her a numbing agent before they try to pull the stent out.Apparently, they did not do that and she experienced stabbing pain to the point she was grabbing the techs.She said the doctor used a cystoscope to remove the stent and she thought something broke and the doctor was having problems to remove the stent.She said the doctor throw away the broken device and got another one and finally removed the stent.

• Brand Name: CYSTOSCOPE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• MDR Report Key: 17086168
• MDR Text Key: 316858445
• Report Number: MW5118259
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/07/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2023
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 82 KG