MAUDE Adverse Event Report: OLYMPUS CIRCON ACMI; CIRCON ACMI OBTURATOR SHEATH

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/26/2014

Event Type  Injury  

Event Description

Pt having a cysto urethrogram when the tip of the obturator sheath broke off and had to be retrieved from the bladder.

• Brand Name: CIRCON ACMI
• Type of Device: CIRCON ACMI OBTURATOR SHEATH
• Manufacturer (Section D): OLYMPUS; southborough MA 01772
• MDR Report Key: 3731813
• MDR Text Key: 16797580
• Report Number: MW5035472
• Device Sequence Number: 1
• Product Code: FBO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/01/2014

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
• Device Operator: Health Professional
• Other Device ID Number: E IS-HCP27
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR