MAUDE Adverse Event Report: GYRUS ACMI INC. USA ELITE SYSTEM ROTATING CF OUTER SHEATH, 25 FR, GOLD

Model Number EROS-CF25

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2015

Event Type  malfunction  

Event Description

Olympus was informed that at the beginning of an unspecified procedure, the white tip of the device broke off after being placed into the patient's bladder.It is unknown if the device fragment was retrieved from the patient.However, there was no patient injury reported.No further information has been provided.Olympus followed up with the user facility to obtain additional information via telephone and in writing regarding the reported event, but with no results.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report is being submitted to correct sections d1, d2, d4, g5, and to provide the device evaluation results.The evaluation did not confirm that the device white tip was broken off.A visual inspection of the device only found that the red dot was missing from the sheath tip.The device was found to function normally when tested.There were no abnormalities observed.

• Brand Name: USA ELITE SYSTEM ROTATING CF OUTER SHEATH, 25 FR, GOLD
• Type of Device: ROTATING CF OUTER SHEATH
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4911185
• MDR Text Key: 6026022
• Report Number: 2951238-2015-00304
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2015

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
• Device Model Number: EROS-CF25
• Device Catalogue Number: EROS-CF25
• Device Lot Number: KM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1