MAUDE Adverse Event Report: ACMI CYSTOSCOPE

Device Problems Device Disinfection Or Sterilization Issue (2909); Material Integrity Problem (2978)

Patient Problem Unspecified Infection (1930)

Event Date 09/18/2015

Event Type  Injury  

Event Description

I received medical procedure that involved a rigid scope to look at my bladder.I acquired an infection after the procedure.I spoke to an acquaintance and the topic of third party repair came up and the fact that no company will validate sterility of any item that is repaired by a third party company only standing behind and validating sterility from the oem.Are these repair companies regulated by the fda and if not why are they allowed to repair medical devices and then be used in medical procedures without being validated for sterility? why as a patient isn't any healthcare provider notifying me that they were using such instrumentation.

• Brand Name: CYSTOSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): ACMI
• MDR Report Key: 5161820
• MDR Text Key: 28806209
• Report Number: MW5057216
• Device Sequence Number: 1
• Product Code: FAJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR