MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS IMRI-FOOT-CTRL_LL; IMRI SURGICAL SYSTEM

Catalog Number IMRI-FOOT-CTRL_LL

Device Problems Air Leak (1008); Overheating of Device (1437); Pressure Problem (3012)

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

Event Date 05/01/2014

Event Type  malfunction  

Event Description

Report 2 of 2 for the same event.It was reported that during a ¿cranial burr hole mri¿ surgical procedure, it was observed that the motor device was leaking air, had low pressure and was getting hot when in use with the foot control device.It was further clarified that the foot control device ¿might be leaking air¿ as well.There were no delays to the scheduled surgical procedure.The reporter indicated that spare devices were not available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.(b)(4) evaluated the device.A functional assessment was performed and the device passed all operational specifications.The reported condition was not confirmed.Therefore, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IMRI-FOOT-CTRL_LL
• Type of Device: IMRI SURGICAL SYSTEM
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 3826692
• MDR Text Key: 4389713
• Report Number: 1045834-2014-12095
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IMRI-FOOT-CTRL_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2014
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOTOR DEVICE