MAUDE Adverse Event Report: CONMED CORP. 15 CUDA BENDABLE TO 30; CUDA SHAVER

Lot Number 567244

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 08/21/2014

Event Type  Injury  

Event Description

Risk received a call from operating room that a piece of the shaver broke off while the surgeon was performing a knee scope.Operating room supervisor reported "it was originally thought a piece of the shaver broke off inside the patient" because the surgeon reported he saw something shiny in the knee on the monitor.He was unable to locate the object visualizing through the scope.He ordered an xray which did not show any foreign object.The device was taken apart in the room but there was no evidence of anything missing or broken off.The consensus was the device did malfunction and the shiny object the surgeon saw might have been a reflection from the light source.The device was removed from service and picked up by patient safety.The procedure was successfully completed.Surgeon did document in his op report how he and the scrub tech thought they saw something shiny but tried to grab it and it moved.He was unable to retrieve it.He continued his surgery and did look again but was unsuccessful in locating it.The knee was irrigated and purged but did not see anything come out.An x-ray was taken.Disclosure to patient family performed of complication.Risk is reporting this as a patient safety concern and possible retained fragment.

• Brand Name: 15 CUDA BENDABLE TO 30
• Type of Device: CUDA SHAVER
• Manufacturer (Section D): CONMED CORP.; 525 french rd.; utica NY 13502
• MDR Report Key: 4093256
• MDR Text Key: 4718724
• Report Number: 4093256
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: Unknown
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Lot Number: 567244
• Other Device ID Number: REF# C9256
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2014
• Distributor Facility Aware Date: 08/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR