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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Unspecified Infection (1930)

Event Date 05/22/2019

Event Type  Injury  

Event Description

Reporter alleges her husband had a cystoscopy. After the procedure on wednesday (b)(6) 2019, he was fine but complained not feeling too good on thursday. On friday, he passed out and the paramedics were called. He was taken to the local hosp and admitted in the icu for 5 days. He had an infection which was bacterial and was placed on different antibiotics. Wife reports she is not too happy her husband was septic after having a cystoscopy and wants the fda to be aware of this incident.

• Brand Name: CYSTOSCOPE FOR CYSTOSCOPY
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
• MDR Report Key: 8874403
• MDR Text Key: 153944258
• Report Number: MW5088897
• 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 FAMILY MEMBER OR FRIEND
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/07/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 08/07/2019 Patient Sequence Number: 1