MAUDE Adverse Event Report: MANUFACTOR UNKNOWN CYSTOSCOPE; CAMERA

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 10/17/2023

Event Type  Injury  

Event Description

The patient's ipp started to auto insufflate, and he woke up as well.As a result, the doctor moved the cystoscope in an aggressive manner.Then, he noticed a perforation of the bladder on the patient's right side.Cystoscopy afterwards confirmed coaptation of the urethra.The balloon was deflated and explanted and the patient's left side remained in.The doctor reports that the perforation was caused by the cystoscope at the end of the procedure because we never saw urine run down the u-channel sheath when using the trocars to deploy the balloon.Uromedia's device was not the cause of this event.

Manufacturer Narrative

Uromedica complaint - (b)(4).

• Brand Name: CYSTOSCOPE
• Type of Device: CAMERA
• Manufacturer (Section D): MANUFACTOR UNKNOWN; unknown; unknown 11111
• Manufacturer (Section G): UNKNOWN NOT OUR DEVICE; unknown; unknown 11111
• Manufacturer Contact: jean russell ; 1840 berkshire lane n; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 18050321
• MDR Text Key: 327099960
• Report Number: 3003477176-2023-00024
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male