MAUDE Adverse Event Report: OLYMPUS OLYMPUS; RESECTION ELECTRODE, ROLLER

Model Number A22251C

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2017

Event Type  malfunction  

Event Description

While using the roller electrode, it was noticed that the roller ball was missing.Dr.(b)(6) checked inside the bladder and under fluoro, while the operating room staff checked the sterile field and around.The roller ball was unable to be located.The rest of the disposable was saved along with the package information.A post op x-ray was taken and read as negative for metallic foreign body.The event was reported to (b)(6) and item made available for pick-up.

• Brand Name: OLYMPUS
• Type of Device: RESECTION ELECTRODE, ROLLER
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 7154416
• MDR Text Key: 96151262
• Report Number: MW5074290
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: A22251C
• Device Lot Number: P1730003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR