MAUDE Adverse Event Report: OSTA USA ELITE CF RESECTOSCOPE INNER SHEATH, 25FR

Model Number EIS-CFR-25

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The cause of the reported event could not be determined; however, the most probably cause could be attributed to the operator's technique.The instruction manual states, "do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.Damage may result in the loss of the entire ceramic tip or fragments of the ceramic tip.If there is evidence of charring, burn spots, chips or cracks in the ceramic tip or surrounding area, do not use.".

Event Description

Olympus was informed that during a transurethral resection of bladder tumor (turbt) procedure, a portion of the ceramic tip broke off inside the patient.The broken tip was retrieved from the patient.The procedure was completed using a different device.No patient injury.

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation confirmed the reported device damage.There was approximately (b)(6) of the ceramic beak missing from the distal end.The device fragment was not returned to olympus.In addition, there were scratches noted on the distal end beak.Based on the investigation findings and similar reported events, the cause of the reported event is likely due to the operator¿s technique.The instruction manual for use states, ¿do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.Damage may result in the loss of the entire ceramic tip or fragments of the ceramic tip.If there is evidence of charring, burn spots, chips or cracks in the ceramic tip or surrounding area, do not use.¿.

• Brand Name: USA ELITE CF RESECTOSCOPE INNER SHEATH, 25FR
• Type of Device: USA ELITE CF RESECTOSCOPE INNER SHEATH, 25FR
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6183672
• MDR Text Key: 62712429
• Report Number: 2951238-2016-00956
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

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: EIS-CFR-25
• Device Catalogue Number: EIS-CFR-25
• Device Lot Number: 0344
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1