MAUDE Adverse Event Report: MANUFACTOR UNKNOWN CYSTOSCOPE; CAMERA

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Internal Organ Perforation (1987); Perforation (2001)

Event Date 10/03/2023

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).

Manufacturer Narrative

Corrected data: section d, #4 "750041".Section e, #1 initial reporter.

• Brand Name: CYSTOSCOPE
• Type of Device: CAMERA
• Manufacturer (Section D): MANUFACTOR UNKNOWN; unknown; unknown 11111
• Manufacturer (Section G): UROMEDICA INC.; 1840 berkshire lane n; plymouth MN 55441
• Manufacturer Contact: jean russell ; 1840 berkshire lane n; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 18049568
• MDR Text Key: 327127733
• Report Number: 3003477176-2023-00023
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023
• 2 Devices were Involved in the Event: 1 2

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
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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