MAUDE Adverse Event Report: OLYMPUS OLYMPUS; ROLLER BALL

Model Number A22251C

Device Problems Break (1069); Thermal Decomposition of Device (1071); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

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

Event Date 12/18/2017

Event Type  malfunction  

Event Description

During a turp, the roller ball on the resectoscope broke off inside the patient, a second product with the same lot number was then used.The second product then malfunctioned and appeared burnt.A bovie pad was used along with sterile water as irrigation.X-ray then called in pacu to check for roller ball, interpreted as negative.

• Brand Name: OLYMPUS
• Type of Device: ROLLER BALL
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 7154299
• MDR Text Key: 96128503
• Report Number: MW5074270
• 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
• 2 Devices were Involved in the Event: 1 2

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: 02/02/2022
• Device Model Number: A22251C
• Device Lot Number: P1730003
• Was Device Available for Evaluation?: Yes
• 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: 66 YR